The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Veripath Peripheral Guiding Catheter.
Device ID | K994229 |
510k Number | K994229 |
Device Name: | VERIPATH PERIPHERAL GUIDING CATHETER |
Classification | Catheter, Percutaneous |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. Temecula, CA 92591 |
Contact | Stacey Simon |
Correspondent | Stacey Simon ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. Temecula, CA 92591 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-12-16 |
Decision Date | 2000-02-25 |
Summary: | summary |