The following data is part of a premarket notification filed by Target Therapeutics with the FDA for Catheter Introducer.
Device ID | K860958 |
510k Number | K860958 |
Device Name: | CATHETER INTRODUCER |
Classification | Introducer, Catheter |
Applicant | TARGET THERAPEUTICS 2100 SOUTH SEPULVEDA BLVD. Los Angeles, CA 90025 |
Contact | Marie Daniels |
Correspondent | Marie Daniels TARGET THERAPEUTICS 2100 SOUTH SEPULVEDA BLVD. Los Angeles, CA 90025 |
Product Code | DYB |
CFR Regulation Number | 870.1340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-03-13 |
Decision Date | 1986-04-23 |