14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55
FDA 510(k) clearance K030502 · decided 2003-05-20
Clearance details
- K-number
- K030502
- Device name
- 14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55
- Applicant
- Medcomp
- Decision
- Substantially Equivalent
- Date received
- 2003-02-19
- Decision date
- 2003-05-20
- Days to decision
- 90 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 |
| THD155428- 15.5F X 28cm Titan HD(TM) Catheter Kit Product Usage: Hemodialysis catheter ins recall (Z-2693-2011) | Medical Components, Inc dba MedComp | 2011-06-28 |