The following data is part of a premarket notification filed by C.r. Bard Inc., Bard Electrophysiology Division with the FDA for Bard Ptfe (teflon) Coated Guide Wires.
| Device ID | K082094 |
| 510k Number | K082094 |
| Device Name: | BARD PTFE (TEFLON) COATED GUIDE WIRES |
| Classification | Wire, Guide, Catheter |
| Applicant | C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION 55 TECHNOLOGY DR. Lowell, MA 01851 |
| Contact | Deborah L Herrington |
| Correspondent | Deborah L Herrington C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION 55 TECHNOLOGY DR. Lowell, MA 01851 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-24 |
| Decision Date | 2008-12-17 |
| Summary: | summary |