MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS
FDA 510(k) clearance K981365 · decided 1998-11-25
Clearance details
- K-number
- K981365
- Device name
- MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS
- Applicant
- Sherwood Medical Co.
- Decision
- Substantially Equivalent
- Date received
- 1998-04-15
- Decision date
- 1998-11-25
- Days to decision
- 224 days
- Clearance type
- Traditional
- Product code
- MSD
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Bothell, WA, 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.