DEEPVESSEL FFR— 510(k) K213657
Substantially EquivalentKeyamed Na, Inc.
FDA 510(k) clearance K213657 for DEEPVESSEL FFR, Substantially Equivalent on 2022-04-01. Applicant: Keyamed Na, Inc.. Device class: 2.
Clearance details
- Applicant
- Keyamed Na, Inc.
- Product code
- Code PJA
- Device class
- Class 2
- Regulation
- 21 CFR 870.1415
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seattle, WA, US
Recent devices under product code PJA
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