The following data is part of a premarket notification filed by Dip, Inc. with the FDA for Percutaneous Introducer Cournand Style.
| Device ID | K812973 |
| 510k Number | K812973 |
| Device Name: | PERCUTANEOUS INTRODUCER COURNAND STYLE |
| Classification | Introducer, Catheter |
| Applicant | DIP, INC. Walker, MI 49504 |
| Contact | James Devries |
| Correspondent | James Devries DIP, INC. Walker, MI 49504 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-23 |
| Decision Date | 1981-11-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10817295020609 | K812973 | 000 |
| 10817295020593 | K812973 | 000 |
| 10817295020456 | K812973 | 000 |
| 10817295020449 | K812973 | 000 |