Medrad Twist & Go High Pressure Connector Tubing
FDA 510(k) K131517 · Medrad, Inc. / Bayer Medical Care, Inc.
510(k) numberK131517
Submission
- Device name
- Medrad Twist & Go High Pressure Connector Tubing
- Applicant
- Medrad, Inc. / Bayer Medical Care, Inc.
Indianola, PA, US - Received
- May 28, 2013
- Decision date
- August 2, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPK – Tubing, Fluid Delivery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K063114 | Disposable Transfer Sets with and Without Swabbable Valves And/Or Check ValvesFPK · Abbreviated | Coeur, Inc. | 02/09/2007SE |
| K063239 | Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528, 17527, 17525 &…FPK · Traditional | Hospira, Inc. | 12/11/2006SE |
| K052431 | Medtronic Minimed Leapfrog II Infusion Set, Models MMT-801S1, MMT-801L1, MMT-801S2…FPK · Traditional | Medtronic Minimed | 11/29/2005SE |
| K041178 | Empower Transfer Set, (Cat. No. 7725)FPK · Traditional | E-Z-Em, Inc. | 07/16/2004SE |
| K031808 | Medrad Swabbable Valve Transfer SetFPK · Special | Medrad, Inc. | 07/11/2003SE |
| K022431 | Medrad Transfer SetFPK · Traditional | Medrad, Inc. | 09/05/2002SE |
| K965208 | Polyfin Extension Set, Models 126 and 128FPK · Traditional | Medtronic Minimed | 02/26/1997SE |
| K953864 | Silclear Tubing (Modification)FPK · Traditional | Degania Silicone , Ltd. | 11/06/1995SE |
| K950508 | Sysmex SF-3000FPK · Traditional | Sysmex Corp. | 11/03/1995SE |
| K952243 | Extension Set/I.V. SetFPK · Traditional | Coast Medical, Inc. | 07/26/1995SE |
More from Coast Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K132928 | Medrad Mark 7 Arterion Injection System / Syringe, Twist & Go SyringeDXT · Special | 01/23/2014SE |
Questions and answers
When was Medrad Twist & Go High Pressure Connector Tubing cleared by the FDA?
Medrad Twist & Go High Pressure Connector Tubing (K131517) received a 510(k) decision of Substantially Equivalent on August 2, 2013, 66 days after the submission was received.
What is the product code of K131517?
The FDA product code is FPK – Tubing, Fluid Delivery, a Class II (moderate risk) device regulated under 21 CFR 880.5440.