The following data is part of a premarket notification filed by Biocompatibles Ltd. with the FDA for 0.014 Floppy & 0.014 Intermediate Guide Wires W/phosphorylcholine Polymer Coating & 4cm Radiopaque Tip.
| Device ID | K961232 |
| 510k Number | K961232 |
| Device Name: | 0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP |
| Classification | Wire, Guide, Catheter |
| Applicant | BIOCOMPATIBLES LTD. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Contact | Nancy F Teague |
| Correspondent | Nancy F Teague BIOCOMPATIBLES LTD. 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 | 1996-03-29 |
| Decision Date | 1996-06-26 |
| Summary: | summary |