The following data is part of a premarket notification filed by Terumo Medical Corporation with the FDA for Transfer Sets.
| Device ID | BK110071 |
| 510k Number | BK110071 |
| Device Name: | Transfer Sets |
| Classification | Set, Transfer (blood/plasma) |
| Applicant | Terumo Medical Corporation 950 Elkton Blvd Elkton, MD 21921 |
| Product Code | KSB |
| CFR Regulation Number | 864.9875 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-30 |
| Decision Date | 2012-09-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05020583620018 | BK110071 | 0 |
| 05020583620001 | BK110071 | 0 |
| 05020583300088 | BK110071 | 0 |
| 05020583300064 | BK110071 | 0 |
| 05020583300040 | BK110071 | 0 |
| 05020583300033 | BK110071 | 0 |