CATHETER INTRODUCER
FDA 510(k) clearance K920528 · decided 1992-08-12
Clearance details
- K-number
- K920528
- Device name
- CATHETER INTRODUCER
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 1992-02-05
- Decision date
- 1992-08-12
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Jose, CA, US
- 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.