5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)— 510(k) K041791
Substantially EquivalentChf Solutions, Inc.
FDA 510(k) clearance K041791 for 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC), Substantially Equivalent on 2004-09-10. Applicant: Chf Solutions, Inc.. Device class: 2.
Clearance details
- Applicant
- Chf Solutions, Inc.
- Product code
- Code NQJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brooklyn Park Mn, MN, US
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