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 |