Sheath Introducer
FDA 510(k) clearance K150932 · decided 2016-07-22
Clearance details
- K-number
- K150932
- Device name
- Sheath Introducer
- Applicant
- Bioteque Corp.
- Decision
- Substantially Equivalent
- Date received
- 2015-04-06
- Decision date
- 2016-07-22
- Days to decision
- 473 days
- Clearance type
- Traditional
- Product code
- DRE
- Device class
- 2
- Regulation number
- 870.1310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Taipei, TW
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.