LWQClass III
Heart-Valve, Mechanical
Unknown
LWQ is the FDA product code for Heart-Valve, Mechanical, a class III device type. As of , FDA records hold no 510(k) clearances under this code and 5 recalls.
Classification record
- Product code
- LWQ
- Device name
- Heart-Valve, Mechanical
- Device class
- Class III
- Review panel
- Unknown
- Submission type
- PMA
- Implant
- Yes
- Life sustaining or supporting
- Yes
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 0
- Ingested recalls
- 5
Companies listing this code with FDA
Companies whose registered establishments list this code- Abbott Medical
- Abbott Medical Costa Rica Limitada (Structural Heart)
- Artivion, Inc.
- Corcym Inc.
- Isomedix Operations Inc
- Medtronic Heart Valves Division
- Medtronic, Inc. (Minneapolis, MN 55447)
- On-X Life Technologies Inc.
- St. Jude Medical Brasil Ltda.
- Sterigenics Costa Rica S.r.l.
- Sterigenics U.S., LLC
- STERIS Isomedix Puerto Rico, Inc.
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