The following data is part of a premarket notification filed by Target Therapeutics with the FDA for Target Catheters And Guide Wires For Pediatric Use.
Device ID | K894084 |
510k Number | K894084 |
Device Name: | TARGET CATHETERS AND GUIDE WIRES FOR PEDIATRIC USE |
Classification | Catheter, Percutaneous |
Applicant | TARGET THERAPEUTICS 130 RIO ROBLES P.O. BOX 610458 San Jose, CA 95134 |
Contact | Marie Daniels |
Correspondent | Marie Daniels TARGET THERAPEUTICS 130 RIO ROBLES P.O. BOX 610458 San Jose, CA 95134 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-06-08 |
Decision Date | 1989-08-17 |