The following data is part of a premarket notification filed by Biocompatibles Cardiovascular, Inc. with the FDA for 6 French, 7 French, And 8 French Guiding Catheters With Phosphorylcholine (pc) Polymer Coating.
Device ID | K962717 |
510k Number | K962717 |
Device Name: | 6 FRENCH, 7 FRENCH, AND 8 FRENCH GUIDING CATHETERS WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING |
Classification | Catheter, Percutaneous |
Applicant | BIOCOMPATIBLES CARDIOVASCULAR, INC. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
Contact | Nancy F Teague |
Correspondent | Nancy F Teague BIOCOMPATIBLES CARDIOVASCULAR, INC. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-12 |
Decision Date | 1997-02-12 |
Summary: | summary |