The following data is part of a premarket notification filed by Cardiovascular Dynamics, Inc. with the FDA for Focus Balloon Dilatation Catheter.
| Device ID | K944016 |
| 510k Number | K944016 |
| Device Name: | FOCUS BALLOON DILATATION CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | CARDIOVASCULAR DYNAMICS, INC. 13844 ALTON PKWY. SUITE 140 Irvine, CA 92718 |
| Contact | Michael Crocker |
| Correspondent | Michael Crocker CARDIOVASCULAR DYNAMICS, INC. 13844 ALTON PKWY. SUITE 140 Irvine, CA 92718 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-16 |
| Decision Date | 1994-12-20 |