The following data is part of a premarket notification filed by Target Therapeutics with the FDA for Rotating Hemostatic Valve.
Device ID | K873971 |
510k Number | K873971 |
Device Name: | ROTATING HEMOSTATIC VALVE |
Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
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 | DTL |
CFR Regulation Number | 870.4290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-29 |
Decision Date | 1988-01-19 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
37613327064712 | K873971 | 000 |