The following data is part of a premarket notification filed by Target Therapeutics with the FDA for Tracker-25 Infusion Catheter.
Device ID | K874751 |
510k Number | K874751 |
Device Name: | TRACKER-25 INFUSION CATHETER |
Classification | Catheter, Percutaneous |
Applicant | TARGET THERAPEUTICS 2100 SOUTH SEPULVEDA BLVD. Los Angeles, CA 90025 |
Contact | Joni M Snyder |
Correspondent | Joni M Snyder TARGET THERAPEUTICS 2100 SOUTH SEPULVEDA BLVD. Los Angeles, CA 90025 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-18 |
Decision Date | 1988-02-12 |