FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device
Needle, Hypodermic, Single Lumen
Teleflex Medical
The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Fast1™ Intraosseous Infusion System; Fastresponder™ Sternal Intraosseous Device.
Pre-market Notification Details
| Device ID | K180588 |
| 510k Number | K180588 |
| Device Name: | FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Teleflex Medical 3015 Carrington Mill Blvd. Morrisville, NC 27560 |
| Contact | Ying Zhao |
| Correspondent | Ying Zhao Teleflex Medical 3015 Carrington Mill Blvd. Morrisville, NC 27560 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-06 |
| Decision Date | 2018-04-17 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 44026704628689 | K180588 | 000 |
| 14026704628671 | K180588 | 000 |
| 40801902203210 | K180588 | 000 |
| 54026704628679 | K180588 | 000 |
Trademark Results [FAST1]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FAST1 77088163 3570363 Live/Registered |
Pyng Medical Corp. 2007-01-22 |
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