DIALYZER, CD-800 COIL
FDA 510(k) clearance K790223 · decided 1979-03-26
Clearance details
- K-number
- K790223
- Device name
- DIALYZER, CD-800 COIL
- Applicant
- Travenol Laboratories, S.A.
- Decision
- Substantially Equivalent
- Date received
- 1979-02-02
- Decision date
- 1979-03-26
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- FHS
- Device class
- 2
- Regulation number
- 876.5820
- 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 |
|---|---|---|
| MICROCOIL 80 DIALYZER (K812811) | Erika, Inc. | 1981-12-03 |
| MICROCOIL 150 DIALYZER (K811974) | Erika, Inc. | 1981-09-16 |
| THE VITA 2 DISPOSABLE DIALYZER (K801634) | Bellco Artifidial Organ Spec., Inc. | 1980-12-17 |
| MICRO-COIL 100 COIL DIALYZER (K800723) | Erika, Inc. | 1980-05-14 |
| GAMBRO LUNDIA COIL DIALYZER (K800174) | Gambro, Inc. | 1980-02-13 |
| DIALYZER, DISP., COIL, LUNDIA (K781102) | Gambro, Inc. | 1978-10-17 |
| MODIFICATION TO KIDNEY DIALYZER (K771349) | Erika, Inc. | 1977-08-02 |
| DIALYZER, COIL, CD, LSA, 5M1765 (K770735) | Travenol Laboratories, S.A. | 1977-05-10 |
| COIL DIALYZER MODEL ALT 140 (K761358) | Bentley Laboratories, Inc. | 1977-01-10 |
| ERI-FLO 900 DIALYZER (K760702) | Erika, Inc. | 1976-11-19 |
| DIALYZER (MODEL 1850) (K760374) | Erika, Inc. | 1976-10-27 |
Recalls involving this device
No recalls on record reference this clearance.