MINI POLYURETHANE CATHETER
FDA 510(k) clearance K982507 · decided 1998-09-16
Clearance details
- K-number
- K982507
- Device name
- MINI POLYURETHANE CATHETER
- Applicant
- Med Institute, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-07-20
- Decision date
- 1998-09-16
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- LJT
- Device class
- 2
- Regulation number
- 880.5965
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- West Lafayette, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.