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 |