Reprocessed BRK Transseptal Needle
FDA 510(k) clearance K192998 · decided 2020-07-22
Clearance details
- K-number
- K192998
- Device name
- Reprocessed BRK Transseptal Needle
- Applicant
- Innovative Health, LLC
- Decision
- Substantially Equivalent
- Date received
- 2019-10-28
- Decision date
- 2020-07-22
- Days to decision
- 268 days
- Clearance type
- Traditional
- Product code
- NMK
- Device class
- 2
- Regulation number
- 870.1390
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Scottsdale, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.