Low Volume Extension Set
FDA 510(k) K864395 · Panamedix, Inc.
510(k) numberK864395
Submission
- Device name
- Low Volume Extension Set
- Applicant
- Panamedix, Inc.
Costa Mesa, CA, US - Received
- November 6, 1986
- Decision date
- December 16, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FPK – Tubing, Fluid Delivery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
Other 510(k)s with product code FPK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K131517 | Medrad Twist & Go High Pressure Connector TubingFPK · Special | Medrad, Inc. / Bayer Medical Care, Inc. | 08/02/2013SE |
| 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 |
More from Sysmex Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K871848 | Nutrition Delivery Sets for VM 05 Ambula. PumpKNT · Traditional | 02/03/1988SE |
| K871843 | Two Fluid W/Check ValveFPA · Traditional | 07/21/1987SE |
| K871842 | Two Fluid I.V. SetsFPA · Traditional | 06/24/1987SE |
| K871841 | Three Fluid I.V. SetsFPA · Traditional | 06/24/1987SE |
| K865051 | Graseby Pcas Model No. 0124-0701, PVS Dytinhr PumpFRN · Traditional | 02/10/1987SE |
Questions and answers
When was Low Volume Extension Set cleared by the FDA?
Low Volume Extension Set (K864395) received a 510(k) decision of Substantially Equivalent on December 16, 1986, 40 days after the submission was received.
What is the product code of K864395?
The FDA product code is FPK – Tubing, Fluid Delivery, a Class II (moderate risk) device regulated under 21 CFR 880.5440.