The following data is part of a premarket notification filed by Intec Medical, Inc. with the FDA for Interflo Medical Model Pa3-h Cco/pac Catheter.
Device ID | K911840 |
510k Number | K911840 |
Device Name: | INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER |
Classification | Catheter, Flow Directed |
Applicant | INTEC MEDICAL, INC. C/O BIOMETRIC RESEARCH INST. 1401 WILSON BLVD., SUITE 400 Arlington, VA 22209 |
Contact | Glenn A Rahmoeller |
Correspondent | Glenn A Rahmoeller INTEC MEDICAL, INC. C/O BIOMETRIC RESEARCH INST. 1401 WILSON BLVD., SUITE 400 Arlington, VA 22209 |
Product Code | DYG |
CFR Regulation Number | 870.1240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-25 |
Decision Date | 1991-06-03 |