DAVOL AUTOTRANSFUSION BLOOD PROCESSING SYSTEM
FDA 510(k) clearance K901401 · decided 1990-10-23
Clearance details
- K-number
- K901401
- Device name
- DAVOL AUTOTRANSFUSION BLOOD PROCESSING SYSTEM
- Applicant
- Davol, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-03-26
- Decision date
- 1990-10-23
- Days to decision
- 211 days
- Clearance type
- Traditional
- Product code
- CAC
- Device class
- 2
- Regulation number
- 868.5830
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Cranston, RI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Davol
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Arista AH (P050038/S042) | Davol, Inc. | 2024-11-04 |
| Arista AH (P050038/S040) | Davol, Inc. | 2023-08-09 |
| FlexiTip XL-R Applicator (P050038/S041) | Davol, Inc. | 2023-05-24 |
| Arista AH Absorbable Hemostatic Particles device (P050038/S038) | Davol, Inc. | 2021-10-22 |
| Arista AH Absorbable Hemostatic Particles Device (P050038/S039) | Davol, Inc. | 2021-08-20 |
| Arista AH Absorbable Hemostatic Particles (P050038/S037) | Davol, Inc. | 2021-07-06 |
| Arista AH Absorbable Hemostatic (P050038/S036) | Davol, Inc. | 2020-09-25 |
| Arista AH Absorbable Hemostatic Particles (P050038/S035) | Davol, Inc. | 2020-04-29 |