HEMOCATH I KIDNEY DIALYSIS CATHETER
FDA 510(k) clearance K801968 · decided 1980-09-26
Clearance details
- K-number
- K801968
- Device name
- HEMOCATH I KIDNEY DIALYSIS CATHETER
- Applicant
- Medical Components, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-08-19
- Decision date
- 1980-09-26
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- LBW
- 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 |
|---|---|---|
| DUAL LUMEN NEEDLES (K904433) | Akcess Medical Products, Inc. | 1990-11-23 |
| MODIFIED DUAL LUMEN NEEDLE (K864629) | Quinton, Inc. | 1986-12-16 |
| DUAL LUMEN NEEDLE (PRODUCT CHANGE) (K860515) | Quinton, Inc. | 1986-03-04 |
| COAXIAL DUAL FLOW CATHETER (K820859) | Terumo Medical Corp. | 1982-04-16 |
Recalls involving this device
No recalls on record reference this clearance.