MAHURKAR TRIPLE LUMEN CATHETER, 12 FR
FDA 510(k) clearance K020089 · decided 2002-04-10
Clearance details
- K-number
- K020089
- Device name
- MAHURKAR TRIPLE LUMEN CATHETER, 12 FR
- Applicant
- The Kendall Company
- Decision
- Substantially Equivalent
- Date received
- 2002-01-10
- Decision date
- 2002-04-10
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- NIE
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mansfield, MA, US
- Third-party review
- No
- Expedited review
- No
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