510(k) K003483
K003483 is an FDA 510(k) premarket notification submitted by Lake Region Mfg., Inc. for the device "MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE)". The FDA issued a decision of Substantially Equivalent on December 6, 2000. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Lake Region Mfg., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 6, 2000
- Date Received
- November 9, 2000
- Clearance Type
- Special
- 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