Vanishpoint Blood Collection Set
FDA 510(k) K112512 · Retractable Technologies, Inc.
510(k) numberK112512
Submission
- Device name
- Vanishpoint Blood Collection Set
- Applicant
- Retractable Technologies, Inc.
Little Elm, TX, US - Received
- August 30, 2011
- Decision date
- October 20, 2011
- 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 |
|---|---|---|
| K202325 | EasyPoint Blood Collection PlusJKA · Traditional | 04/09/2021SE |
| K133635 | Easypoint NeedleFMI · Traditional | 06/17/2014SE |
| K122355 | Vanishpoint Blood Collection SetJKA · Traditional | 08/23/2013SE |
| K101708 | Patient Safe Luer CapFMF · Traditional | 02/24/2011SE |
| K081420 | Vanishpoint I.V. CatheterFOZ · Abbreviated | 11/07/2008SE |
| K072654 | Patient Safe SyringeFMF · Traditional | 12/14/2007SE |
| K051355 | Vanishpoint I.V. CatheterFOZ · Traditional | 09/23/2005SE |
| K980069 | Vanishpoint SyringeMEG · Traditional | 02/12/1998SE |
| K973301 | Anti-Stick Syringe with Integral Hypodermic Needle/Vanishpoint SyringeMEG · Traditional | 11/07/1997SE |
| K971763 | Blood Collection Tube Holder Vanishpoint Tube Holder/Small Tube AdapterFMI · Traditional | 08/26/1997SE |
Questions and answers
When was Vanishpoint Blood Collection Set cleared by the FDA?
Vanishpoint Blood Collection Set (K112512) received a 510(k) decision of Substantially Equivalent on October 20, 2011, 51 days after the submission was received.
What is the product code of K112512?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.