Kaplan-Simpson InfusaSleeve II Catheter
FDA 510(k) clearance K952317 · decided 1995-06-28
Clearance details
- K-number
- K952317
- Device name
- Kaplan-Simpson InfusaSleeve II Catheter
- Applicant
- Localmed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-05-17
- Decision date
- 1995-06-28
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- QEY
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Palo Alto, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.