The following data is part of a premarket notification filed by Target Therapeutics with the FDA for Guide Wire Introducer.
Device ID | K873972 |
510k Number | K873972 |
Device Name: | GUIDE WIRE INTRODUCER |
Classification | Wire, Guide, Catheter |
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 | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-29 |
Decision Date | 1988-04-01 |