The following data is part of a premarket notification filed by Covidien Llc with the FDA for Wholey Guide Wire System.
| Device ID | K120863 |
| 510k Number | K120863 |
| Device Name: | WHOLEY GUIDE WIRE SYSTEM |
| Classification | Wire, Guide, Catheter |
| Applicant | Covidien LLC 3033 Campus Drive Plymouth, MN 55441 |
| Contact | David Rbertson |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-03-22 |
| Decision Date | 2012-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821684065877 | K120863 | 000 |
| 20763000185811 | K120863 | 000 |
| 20763000185804 | K120863 | 000 |
| 20763000185767 | K120863 | 000 |
| 20763000185750 | K120863 | 000 |
| 20763000185743 | K120863 | 000 |
| 20763000185736 | K120863 | 000 |
| 20763000185729 | K120863 | 000 |
| 20763000185712 | K120863 | 000 |
| 20763000185705 | K120863 | 000 |
| 20763000185699 | K120863 | 000 |
| 20763000185682 | K120863 | 000 |
| 20763000185675 | K120863 | 000 |
| 20763000185668 | K120863 | 000 |
| 00821684058602 | K120863 | 000 |
| 00821684058619 | K120863 | 000 |
| 00821684058596 | K120863 | 000 |
| 00821684058725 | K120863 | 000 |
| 00821684058718 | K120863 | 000 |
| 00821684058701 | K120863 | 000 |
| 00821684058695 | K120863 | 000 |
| 00821684058688 | K120863 | 000 |
| 00821684058671 | K120863 | 000 |
| 00821684058664 | K120863 | 000 |
| 00821684058657 | K120863 | 000 |
| 00821684058640 | K120863 | 000 |
| 00821684058633 | K120863 | 000 |
| 00821684058626 | K120863 | 000 |
| 00821684049389 | K120863 | 000 |
| 00821684049372 | K120863 | 000 |
| 20763000185651 | K120863 | 000 |