The following data is part of a premarket notification filed by Spectramed, Inc. with the FDA for Heparin Coated Luminal Pacing Catheter.
Device ID | K875337 |
510k Number | K875337 |
Device Name: | HEPARIN COATED LUMINAL PACING CATHETER |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard, CA 93030 |
Contact | Robert L Leavitt |
Correspondent | Robert L Leavitt SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard, CA 93030 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-30 |
Decision Date | 1988-05-25 |