510(k) K902153
K902153 is an FDA 510(k) premarket notification submitted by Guidewire Technologies, Inc. for the device "TEFLON COATED GUIDEWIRE". The FDA issued a decision of Substantially Equivalent on Jul 31, 1990. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Guidewire Technologies, Inc. has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 31, 1990
- Date Received
- May 16, 1990
- 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)