The following data is part of a premarket notification filed by Cardiovascular Dynamics, Inc. with the FDA for Focus-pv Balloon Dilatation Catheter.
| Device ID | K971577 |
| 510k Number | K971577 |
| Device Name: | FOCUS-PV BALLOON DILATATION CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | CARDIOVASCULAR DYNAMICS, INC. 13700 ALTON PKWY. Irvine, CA 92618 |
| Contact | Pam Misajon |
| Correspondent | Pam Misajon CARDIOVASCULAR DYNAMICS, INC. 13700 ALTON PKWY. Irvine, CA 92618 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-21 |
| Decision Date | 1997-06-18 |
| Summary: | summary |