The following data is part of a premarket notification filed by Abbott Vascular-cardiac Therapies with the FDA for Hi-torque Pilot 50 And 150 Guide Wire With Hydrocoat Hydrophilic Coating, Hi-torque Whisper Ls And Ms Guide Wire With.
| Device ID | K101116 |
| 510k Number | K101116 |
| Device Name: | HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH |
| Classification | Wire, Guide, Catheter |
| Applicant | ABBOTT VASCULAR-CARDIAC THERAPIES 26531 YNEZ RD. MAILING P.O. BOX 9018 Temecula, CA 92589 -9018 |
| Contact | Kay Setzer |
| Correspondent | Kay Setzer ABBOTT VASCULAR-CARDIAC THERAPIES 26531 YNEZ RD. MAILING P.O. BOX 9018 Temecula, CA 92589 -9018 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-21 |
| Decision Date | 2010-06-23 |
| Summary: | summary |