FDA Product Code
FDA Product Code LDF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3680
510(k) Clearances — 130 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K831645 | TEMP. BIPOLAR EPICARDIAL LEAD | Cordic Corp. | 1983-07-26 | Traditional | PDF ↗ |
| K830772 | TEMP. PACING LEAD, BIPOLAR #TH60, 90/110 | Oscor, Inc. | 1983-04-18 | Traditional | PDF ↗ |
| K830094 | USCI TEMP. ATRIO-VENTRICULAR ELECTRODE | C.R. Bard, Inc. | 1983-02-18 | Traditional | PDF ↗ |
| K822002 | BIPOLAR TEMP. PACING CATHETER W/STYLETET | Ziehm International, Inc. | 1982-10-15 | Traditional | PDF ↗ |
| K822003 | BALLOON TEMP. PACING CATHETER | Ziehm International, Inc. | 1982-10-15 | Traditional | PDF ↗ |
| K822155 | ETHICON TEMPORARY CARDIAC PACING WIRE | ETHICON, Inc. | 1982-08-24 | Traditional | PDF ↗ |
| K821518 | MYO/CLIP | Alto Development Corp. | 1982-07-08 | Traditional | PDF ↗ |
| K821333 | ATRIAL J TEMPORARY PACING ELECTRODESS | Medics Instrument Corp. | 1982-06-02 | Traditional | PDF ↗ |
| K820232 | TRANSTHORACIC TEMP. PACEMAKER #100TPE | Trans Pace, Inc. | 1982-04-09 | Traditional | PDF ↗ |
| K820003 | CARDIOVASCULAR TEMP. PACEMAKER ELEC | Diag Corp. | 1982-03-26 | Traditional | PDF ↗ |
| K813521 | TRANSLUMINAL BIPOLAR PACING PROBE | American Edwards Laboratories | 1982-03-15 | Traditional | PDF ↗ |
| K813138 | ETHICON* TEMP. CARDIAC PACING WIRE | ETHICON, Inc. | 1981-12-10 | Traditional | PDF ↗ |
| K812725 | MODEL 5867-12 BIPOLAR LOW-PROFILE LEAD | Medtronic Vascular | 1981-11-16 | Traditional | PDF ↗ |
| K812781 | TEMPORARY PERVENOUS J-ATRIAL LEAD | Cordis Corp. | 1981-10-29 | Traditional | PDF ↗ |
| K812517 | CARDIAC PACING ELECTRODES | Medics Instrument Corp. | 1981-10-13 | Traditional | PDF ↗ |
| K812307 | USCI TRANSTHORACIC TEMP. PACING ELECTROD | C.R. Bard, Inc. | 1981-09-21 | Traditional | PDF ↗ |
| K811318 | TEMPORARY ENDOCARDIAL TRIPOLAR LD. #6880 | Medtronic Vascular | 1981-07-20 | Traditional | PDF ↗ |
| K803086 | MYOWIRE-ATEMPORARY CARDIAC PACING WIRE | Craig & Craig, Inc. | 1981-07-01 | Traditional | PDF ↗ |
| K810642 | ATRIAL-VENTRICULAR PACING ELECTRODE KIT | Stanco Medical, Inc. | 1981-04-08 | Traditional | PDF ↗ |
| K810657 | TEMPTRON #'S 6804/6805 | Medtronic Vascular | 1981-04-08 | Traditional | PDF ↗ |
| K810643 | UNIVERSAL PACING ELECTRODE KIT | Stanco Medical, Inc. | 1981-04-08 | Traditional | PDF ↗ |
| K810312 | ELECATH DUAL MODE TRANSTHORACIC PACING | Electro-Catheter Corp. | 1981-03-04 | Traditional | PDF ↗ |
| K810041 | CORDIS TEMPORATY CURVED ATRIAL LEAD | Cordis Corp. | 1981-02-05 | Traditional | PDF ↗ |
| K803058 | SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH. | American Edwards Laboratories | 1981-01-16 | Traditional | PDF ↗ |
| K801799 | ATRIAL/VENTRICULAR SEQENTIAL #080-20000 | Medical Testing System, Inc. | 1981-01-02 | Traditional | PDF ↗ |
| K801800 | UNIVERSAL TEMP. PACING ELECT. #080-10000 | Medical Testing System, Inc. | 1980-10-23 | Traditional | PDF ↗ |
| K802259 | TRANSVENOUS PACEMAKER ELECTRODE KIT | Stanco Medical, Inc. | 1980-10-23 | Traditional | PDF ↗ |
| K800298 | USCI BIPOLAR BALLON PACING ELECTRODE | C.R. Bard, Inc. | 1980-04-16 | Traditional | PDF ↗ |
| K791183 | SWAN-GANZ FLOW-DIRECTED CATHETER | Edwards Lifesciences, LLC | 1979-07-12 | Traditional | PDF ↗ |
| K781002 | TEMPORARY CARDIAC PACING WIRE | ETHICON, Inc. | 1978-12-04 | Traditional | PDF ↗ |
Product code LDF · Class II · Cardiovascular. Data: openFDA.