← Back to catalogue
Iso-Gard Filter Straight - Humid-Vent Filter Compact Angled
FDA 510(k)Class II (US FDA 510(k))
510(k) K252643
Identifiers
- 510(k) Number
- K252643 FDA 510(k)
- FDA Product Code
- CAH FDA 510(k)
- Models / Variants
- Iso-Gard Filter Straight FDA 510(k)Humid-Vent Filter Compact Angled FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5260 FDA 510(k)
- Regulation Number
- 868.5260 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Iso-Gard Filter Straight - Humid-Vent Filter Compact Angled by Teleflex Medical Sdn. Bhd. — Class II — FDA_510K — listed in FDA 510(k) — 2 models
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 | K252643 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Teleflex Medical Sdn. Bhd.
Sources (1)
- FDA 510(k) K252643 24 fields · synced Jun 18, 2026