HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40
FDA 510(k) clearance K994105 · decided 2001-10-03
Clearance details
- K-number
- K994105
- Device name
- HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40
- Applicant
- Medical Components, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-12-06
- Decision date
- 2001-10-03
- Days to decision
- 667 days
- Clearance type
- Traditional
- Product code
- MSD
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Harleysville, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion C recall (Z-1351-2015) | Medical Components, Inc dba MedComp | 2015-03-30 |