Safeline System Turn Lock Cannula
FDA 510(k) K941244 · Mcgaw, Inc.
510(k) numberK941244
Submission
- Device name
- Safeline System Turn Lock Cannula
- Applicant
- Mcgaw, Inc.
Irvine, CA, US - Received
- March 15, 1994
- Decision date
- November 29, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K972678 | Millennium CRT Infusion Pump and Millennium CRT Infusion Pump Administration SetsFRN · Traditional | 10/07/1997SE |
| K955595 | Safeline Multidose Vial AdapterLHI · Traditional | 03/06/1996SE |
| K955594 | Safeline I.V. Bag Access DeviceLHI · Traditional | 03/06/1996SE |
| K932165 | Intravascular Administration SetFPA · Traditional | 04/13/1994SE |
| K931377 | Safeline System IV Administration Sets & ComponentFPA · Traditional | 03/07/1994SE |
| K932856 | Irrigation Access CapFPA · Traditional | 01/26/1994SE |
| K922637 | Horizon Pump Y-Type Blood SetFPA · Traditional | 06/04/1993SE |
| K921860 | Modification to IV SpikeFPA · Traditional | 07/30/1992SE |
| K913661 | Modified Volumetric Infusion PumpFRN · Traditional | 12/18/1991SE |
| K913056 | Volumetric Infusion Pump, ModificationFRN · Traditional | 09/06/1991SE |
Questions and answers
When was Safeline System Turn Lock Cannula cleared by the FDA?
Safeline System Turn Lock Cannula (K941244) received a 510(k) decision of Substantially Equivalent on November 29, 1994, 259 days after the submission was received.
What is the product code of K941244?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.