COBE ACUFLEX FSN, #15-208
FDA 510(k) clearance K820237 · decided 1982-03-10
Clearance details
- K-number
- K820237
- Device name
- COBE ACUFLEX FSN, #15-208
- Applicant
- Cobe Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-01-28
- Decision date
- 1982-03-10
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- LFK
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH) (K971897) | Medron, Inc. | 1997-10-21 |
| CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET (K914936) | Akcess Medical Products, Inc. | 1992-04-23 |
| CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS (K915215) | Akcess Medical Products, Inc. | 1992-03-27 |
| FC-101 FEMORAL CATHETER GUIDE WIRE (K891764) | Akcess Medical Products, Inc. | 1989-04-07 |
| FC-100 FEMORAL CATHETER (K891763) | Akcess Medical Products, Inc. | 1989-04-07 |
| MODIFICATION HEMOFILTRATION CATHETER HF-100 (K890717) | Vas-Cath, Inc. | 1989-04-05 |
| CONTINUOUS ARTERIAL/VENOUS HEMOFILTRATION TRAY (K880775) | Medsurg Industries, Inc. | 1988-07-25 |
| VAS-CATH PEDIATRIC HEMOFILTRATION CATHETER (K882466) | Vas-Cath, Inc. | 1988-07-13 |
| NEW SECOND FRENCH SIZE MAHURKAR CATHETER (K865096) | Quinton, Inc. | 1987-02-18 |
| CYTOSTATIC FILTRATION SET (K863218) | Meadox Surgimed, Inc. | 1987-02-12 |
| MEDCOMP C.A.V.H. CATHETER (K862771) | Medical Components, Inc. | 1986-08-06 |
| MEDCOMP'S FEMORAL VEIN CATHETERS (K860810) | Medical Components, Inc. | 1986-04-08 |
Recalls involving this device
No recalls on record reference this clearance.