510(k) BK210658
- Device
- Container, Empty, For The Collection '& Processing Of Blood/Blood Components
- Applicant
- Terumo BCT, Inc
- 510(k) number
- BK210658
- Product code
- KSR
- Decision
- Substantially Equivalent (SE)
- Decision date
- 2022-08-26
- Date received
- 2021-12-02
- Regulation
- 864.9100
- Classification name
- Container, Empty, For Collection & Processing Of Blood & Blood Components
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Clearance type
- 510(k) Traditio
- Third party reviewed
- No
Other 510(k) Records For Product Code KSR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K032827 | KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 | Tyco Healthcare | 2003-12-08 |
| K020753 | DEROYAL SURGICAL, UMBILICUP | Deroyal | 2002-06-13 |
| K810500 | BLOOD FREEZING BAG | Delmed, Inc. | 1981-09-23 |
| K810897 | ALPHA PLASTIC PLASMA BOTTLE | Alpha Therapeutic Corp. | 1981-09-23 |
| K811523 | PLASMA FLEX | Terumo America, Inc. | 1981-09-09 |
| K811449 | HAEMONETICS 1000ML COMPONENT BAG | Haemonetics Corp. | 1981-07-01 |
| K810711 | HAEMONETICS 600 ML. COMPONENT BAG | Haemonetics Corp. | 1981-05-08 |
| K810313 | HAEMONETICS 1400 ML THERAPEUTIC BAG | Haemonetics Corp. | 1981-03-31 |
| K801082 | GAMBRO HEMOFREEZE-BAG | Gambro, Inc. | 1980-10-31 |
| K801219 | PLASMAPOOLER | North American Biologicals, Inc. | 1980-10-31 |
| K792395 | PHARMAFLEX CRYOGENIC BAG | Pharmachem Corp. | 1980-02-26 |
| K792185 | PIASMA SAFE | Cry-O-Safe, Inc. | 1979-12-28 |
| K791673 | EMPTY TRANSFER BAG | Delmed, Inc. | 1979-10-23 |
| K781811 | TRANSFER PAK 4R 9006 | Travenol Laboratories, S.A. | 1978-11-08 |
| K780354 | CRYOCYTE PACK | Travenol Laboratories, S.A. | 1978-06-14 |
Legacy Summary#
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FDA Review#
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