The following data is part of a premarket notification filed by Cardio Vascular Concepts, Inc. with the FDA for Rapid-trak(tm) Introducer Sheath.
| Device ID | K950155 |
| 510k Number | K950155 |
| Device Name: | RAPID-TRAK(TM) INTRODUCER SHEATH |
| Classification | Introducer, Catheter |
| Applicant | CARDIO VASCULAR CONCEPTS, INC. 3260 ALPINE RD. Portola Valley, CA 94028 |
| Contact | Jay Lenker |
| Correspondent | Jay Lenker CARDIO VASCULAR CONCEPTS, INC. 3260 ALPINE RD. Portola Valley, CA 94028 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-17 |
| Decision Date | 1995-08-02 |