The following data is part of a premarket notification filed by Cardiovascular Dynamics, Inc. with the FDA for 22 Gauge P.d. Access Vascular Access Device (catheter/needle Assembly), 24 Gauge P.d. Access Vascular Access Device (car.
| Device ID | K973713 |
| 510k Number | K973713 |
| Device Name: | 22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | CARDIOVASCULAR DYNAMICS, INC. 13700 ALTON PKWY. Irvine, CA 92618 |
| Contact | Pamela Misajon |
| Correspondent | Pamela Misajon CARDIOVASCULAR DYNAMICS, INC. 13700 ALTON PKWY. 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 | 1997-09-29 |
| Decision Date | 1998-01-23 |
| Summary: | summary |