SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514
FDA 510(k) clearance K022489 · decided 2002-10-09
Clearance details
- K-number
- K022489
- Device name
- SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514
- Applicant
- Summit Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2002-07-29
- Decision date
- 2002-10-09
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- CAC
- Device class
- 2
- Regulation number
- 868.5830
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Stevenage Hertfordshire, GB
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Summit Medical
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.