Reprocessed Catheter Introducer
FDA product code PNE · 7 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.1340
- Review panel
- CV
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 2016-03-23 – 2026-01-07
Introduce various cardiovascular catheters into the heart and cardiovascular system
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Reprocessed Carto Vizigo Bi-Directional Guiding Sheath
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PNE
2016-03-23
Reprocessed Steerable Introducer
View details →No matching devices.
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