KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501
FDA 510(k) clearance K032827 · decided 2003-12-08
Clearance details
- K-number
- K032827
- Device name
- KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501
- Applicant
- Tyco Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2003-09-10
- Decision date
- 2003-12-08
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- KSR
- Device class
- 2
- Regulation number
- 864.9100
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mansfield, MA, 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 |
|---|---|---|
| DEROYAL SURGICAL, UMBILICUP (K020753) | Deroyal | 2002-06-13 |
| ALPHA PLASTIC PLASMA BOTTLE (K810897) | Alpha Therapeutic Corp. | 1981-09-23 |
| BLOOD FREEZING BAG (K810500) | Delmed, Inc. | 1981-09-23 |
| PLASMA FLEX (K811523) | Terumo America, Inc. | 1981-09-09 |
| HAEMONETICS 1000ML COMPONENT BAG (K811449) | Haemonetics Corp. | 1981-07-01 |
| HAEMONETICS 600 ML. COMPONENT BAG (K810711) | Haemonetics Corp. | 1981-05-08 |
| HAEMONETICS 1400 ML THERAPEUTIC BAG (K810313) | Haemonetics Corp. | 1981-03-31 |
| GAMBRO HEMOFREEZE-BAG (K801082) | Gambro, Inc. | 1980-10-31 |
| PLASMAPOOLER (K801219) | North American Biologicals, Inc. | 1980-10-31 |
| PHARMAFLEX CRYOGENIC BAG (K792395) | Pharmachem Corp. | 1980-02-26 |
| PIASMA SAFE (K792185) | Cry-O-Safe, Inc. | 1979-12-28 |
| EMPTY TRANSFER BAG (K791673) | Delmed, Inc. | 1979-10-23 |
Recalls involving this device
No recalls on record reference this clearance.