V-HEPES PLUS
FDA 510(k) clearance K213293 · decided 2022-09-14
Clearance details
- K-number
- K213293
- Device name
- V-HEPES PLUS
- Applicant
- Vitromed Langenfeld
- Decision
- Substantially Equivalent
- Date received
- 2021-10-01
- Decision date
- 2022-09-14
- Days to decision
- 348 days
- Clearance type
- Traditional
- Product code
- MQL
- Device class
- 2
- Regulation number
- 884.6180
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Langenfeld, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.