510(k) BK170098
- Device
- Transfer Sets
- Applicant
- Terumo BCT, Inc
- 510(k) number
- BK170098
- Product code
- KSB
- Decision
- Substantially Equivalent (SE)
- Decision date
- 2017-09-29
- Date received
- 2017-08-30
- Regulation
- 864.9875
- Classification name
- Set, Transfer (blood/plasma)
- 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) Special
- Third party reviewed
- No
Other 510(k) Records For Product Code KSB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K172957 | Kawasumi Laboratories Blood Drawing Kit (BDK) System | Kawasumi Laboratories, Inc. | 2018-09-28 |
| K001043 | KAWASUMI LABORATORY BLOOD DRAWING KIT | Kawasumi Laboratories America, Inc. | 2000-05-19 |
| K820447 | ALPHA PLASMA TRANSFER SET | Alpha Therapeutic Corp. | 1982-04-14 |
| K802940 | SUPER-SPIKE TRANSFER SET | Geneva Laboratories, Inc. | 1981-01-15 |
| K791130 | FLU-VEN TK-2 | Venospital, Inc. | 1979-09-04 |
| K791131 | FLU VEN TR-1 | Venospital, Inc. | 1979-09-04 |
Legacy Summary#
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FDA Review#
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