FDA Product Code
FDA Product Code DRE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1310
510(k) Clearances — 105 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K802327 | SHEATH DILATOR SET | Stanco Medical, Inc. | 1980-10-10 | Traditional | PDF ↗ |
| K801113 | DILATOR, VESSEL, FOR PERC. CATHETER. | Alva Medical, Inc. | 1980-07-28 | Traditional | PDF ↗ |
| K800462 | PERCUTANEOUS INTRODUCER SET | Medical Components, Inc. | 1980-03-19 | Traditional | PDF ↗ |
| K780126 | DILATOR, VESSEL & INTRODUCER, SHEATH | Argon Medical Corp. | 1978-03-02 | Traditional | PDF ↗ |
| K760403 | TEMPORARY ATRIAL ELECTRODE KIT | Usci, Div. C.R. Bard, Inc. | 1976-08-23 | Traditional | PDF ↗ |
Product code DRE · Class II · Cardiovascular. Data: openFDA.