The following data is part of a premarket notification filed by Boston Scientific Scimed, Inc. with the FDA for Pt2 Guide Wire And Addwire Extension Wire.
| Device ID | K030617 |
| 510k Number | K030617 |
| Device Name: | PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | BOSTON SCIENTIFIC SCIMED, INC. ONE SCIMED PLACE Maple Grove, MN 55311 |
| Contact | Anne V Rossi |
| Correspondent | Anne V Rossi BOSTON SCIENTIFIC SCIMED, INC. ONE SCIMED PLACE Maple Grove, MN 55311 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-26 |
| Decision Date | 2003-05-21 |
| Summary: | summary |