510(k) K951307

BAXTER TREK *14 INTERMEDIATE AND SUPPORT GUIDEWIRES by Baxter Healthcare Corp — Product Code DQX

K951307 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "BAXTER TREK *14 INTERMEDIATE AND SUPPORT GUIDEWIRES". The FDA issued a decision of Substantially Equivalent on Jun 22, 1995. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Baxter Healthcare Corp has 507 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 22, 1995
Date Received
Mar 22, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type
510(k)

Source: FDA 510(k) database entry for K951307. Report a data issue: hello@regdatalab.com.