KSR — Container, Empty, For Collection & Processing Of Blood & Blood Components Class II
FDA product code KSR covers "Container, Empty, For Collection & Processing Of Blood & Blood Components", a Class II medical device regulated under 21 CFR 864.9100. Submissions are reviewed by the Hematology panel. At least 16 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KSR
- Device Class
- Class II
- Regulation Number
- 864.9100
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K032827 | tyco healthcare | KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 | December 8, 2003 |
| K020753 | deroyal | DEROYAL SURGICAL, UMBILICUP | June 13, 2002 |
| K810500 | delmed | BLOOD FREEZING BAG | September 23, 1981 |
| K810897 | alpha therapeutic | ALPHA PLASTIC PLASMA BOTTLE | September 23, 1981 |
| K811523 | terumo america | PLASMA FLEX | September 9, 1981 |
| K811449 | haemonetics | HAEMONETICS 1000ML COMPONENT BAG | July 1, 1981 |
| K810711 | haemonetics | HAEMONETICS 600 ML. COMPONENT BAG | May 8, 1981 |
| K810313 | haemonetics | HAEMONETICS 1400 ML THERAPEUTIC BAG | March 31, 1981 |
| K801082 | gambro | GAMBRO HEMOFREEZE-BAG | October 31, 1980 |
| K801219 | north american biologicals | PLASMAPOOLER | October 31, 1980 |
| K792395 | pharmachem | PHARMAFLEX CRYOGENIC BAG | February 26, 1980 |
| K792185 | cry-o-safe | PIASMA SAFE | December 28, 1979 |
| K791673 | delmed | EMPTY TRANSFER BAG | October 23, 1979 |
| K781811 | travenol laboratories | TRANSFER PAK 4R 9006 | November 8, 1978 |
| K780354 | travenol laboratories | CRYOCYTE PACK | June 14, 1978 |
| K760952 | dravon medical | TERASAKI LYMPHOCYTE TRANSPORT KIT | January 17, 1977 |