The following data is part of a premarket notification filed by Terumo (philippines) Corporation with the FDA for Terumo Surflo I.v. Catheter.
| Device ID | K133280 |
| 510k Number | K133280 |
| Device Name: | TERUMO SURFLO I.V. CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | TERUMO (PHILIPPINES) CORPORATION 950 ELKTON BLVD Elkton, MD 21921 |
| Contact | Phillip Lester |
| Correspondent | Phillip Lester TERUMO (PHILIPPINES) CORPORATION 950 ELKTON BLVD Elkton, MD 21921 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-25 |
| Decision Date | 2014-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 54806017512281 | K133280 | 000 |
| 74806017510151 | K133280 | 000 |
| 74806017510168 | K133280 | 000 |
| 54806017510171 | K133280 | 000 |
| 74806017510182 | K133280 | 000 |
| 54806017510195 | K133280 | 000 |
| 54806017512229 | K133280 | 000 |
| 54806017512236 | K133280 | 000 |
| 74806017512247 | K133280 | 000 |
| 54806017512250 | K133280 | 000 |
| 54806017512267 | K133280 | 000 |
| 74806017512278 | K133280 | 000 |
| 74806017510144 | K133280 | 000 |