The following data is part of a premarket notification filed by Biocompatibles Cardiovascular, Inc. with the FDA for Hunter 0.014 Inch Super Soft / Hunter O.014 Inch Soft Guide Wires W/thromboresistant Pc Coating.
Device ID | K970938 |
510k Number | K970938 |
Device Name: | HUNTER 0.014 INCH SUPER SOFT / HUNTER O.014 INCH SOFT GUIDE WIRES W/THROMBORESISTANT PC COATING |
Classification | Wire, Guide, Catheter |
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 | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-03-13 |
Decision Date | 1997-11-17 |
Summary: | summary |