The following data is part of a premarket notification filed by Abbott Vascular Inc. with the FDA for Progress Guide Wire Family, Pilot Guide Wire Family.
| Device ID | K123067 |
| 510k Number | K123067 |
| Device Name: | PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY |
| Classification | Wire, Guide, Catheter |
| Applicant | ABBOTT VASCULAR INC. P.O. BOX 9018 Temecula, CA 92591 -9018 |
| Contact | Sean Mullin |
| Correspondent | Sean Mullin ABBOTT VASCULAR INC. P.O. BOX 9018 Temecula, CA 92591 -9018 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-01 |
| Decision Date | 2013-01-29 |
| Summary: | summary |