The following data is part of a premarket notification filed by Cardiovascular Dynamics, Inc. with the FDA for P.d. Access (percutaneous Doppler) Vascular Access Device.
| Device ID | K963989 |
| 510k Number | K963989 |
| Device Name: | P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | CARDIOVASCULAR DYNAMICS, INC. 13900 ALTON PKWY. SUITE 122 Irvine, CA 92618 |
| Contact | Michael Crocker |
| Correspondent | Michael Crocker CARDIOVASCULAR DYNAMICS, INC. 13900 ALTON PKWY. SUITE 122 Irvine, CA 92618 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-04 |
| Decision Date | 1997-04-24 |
| Summary: | summary |