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Introducer Sheath - PFlexi30L070
FDA 510(k)Class II (US FDA 510(k))
510(k) K242756
Identifiers
- 510(k) Number
- K242756 FDA 510(k)
- FDA Product Code
- DYB FDA 510(k)
- Models / Variants
- PFlexi00L065 FDA 510(k)PFlexi00L070 FDA 510(k)PFlexi00L075 FDA 510(k)PFlexi00L080 FDA 510(k)PFlexi00L090 FDA 510(k)PFlexi30L065 FDA 510(k)PFlexi30L070 FDA 510(k)PFlexi30L075 FDA 510(k)PFlexi30L080 FDA 510(k)PFlexi30L090 FDA 510(k)PFlexi45L065 FDA 510(k)PFlexi45L070 FDA 510(k)PFlexi45L075 FDA 510(k)PFlexi45L080 FDA 510(k)PFlexi45L090 FDA 510(k)PFlexi60L065 FDA 510(k)PFlexi60L070 FDA 510(k)PFlexi60L075 FDA 510(k)PFlexi60L080 FDA 510(k)PFlexi60L090 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1340 FDA 510(k)
- Regulation Number
- 870.1340 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Introducer Sheath - PFlexi30L070 by Pulnovo Medical (Wuxi) Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 20 models — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242756 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulnovo Medical (Wuxi) Co., Ltd.
Sources (1)
- FDA 510(k) K242756 24 fields · synced Jun 18, 2026