The following data is part of a premarket notification filed by Target Therapeutics with the FDA for Target Therapeutics Radiopaque Stylet.
Device ID | K914001 |
510k Number | K914001 |
Device Name: | TARGET THERAPEUTICS RADIOPAQUE STYLET |
Classification | Stylet, Catheter |
Applicant | TARGET THERAPEUTICS 130 RIO ROBLES P.O. BOX 610458 San Jose, CA 95134 |
Contact | Wendy J Zenzen |
Correspondent | Wendy J Zenzen TARGET THERAPEUTICS 130 RIO ROBLES P.O. BOX 610458 San Jose, CA 95134 |
Product Code | DRB |
CFR Regulation Number | 870.1380 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-09-06 |
Decision Date | 1991-11-22 |