Churchill Extension Tube
FDA 510(k) K861626 · Churchill Corp.
510(k) numberK861626
Submission
- Device name
- Churchill Extension Tube
- Applicant
- Churchill Corp.
Langhorne, PA, US - Received
- April 22, 1986
- Decision date
- June 2, 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 |
|---|---|---|
| K880051 | Enteral Bag/SetKNT · Traditional | 04/14/1988SE |
| K880026 | Churchill 0.22 Micron Liquid Compact Filter SetsFPB · Traditional | 04/14/1988SE |
| K880025 | Churchill 0.22 Micron Liquid Filter SetsFPB · Traditional | 04/14/1988SE |
| K880027 | Churchill 1.2 Micron Liquid Filter SetFPB · Traditional | 04/13/1988SE |
| K872585 | Churchill-CathFOZ · Traditional | 10/15/1987SE |
| K870395 | Churchill Parenteral Nutrition Bag - EvaKPE · Traditional | 10/15/1987SE |
| K872124 | Churchill Albumin IV Administration SetFPA · Traditional | 10/13/1987SE |
| K872123 | Churchill TPN Administration SetFPA · Traditional | 10/09/1987SE |
| K872043 | Churchill Inter-Cardiac SuckerDWF · Traditional | 09/30/1987SE |
| K871084 | Nitroglycerine Pump SetFRN · Traditional | 07/16/1987SE |
Questions and answers
When was Churchill Extension Tube cleared by the FDA?
Churchill Extension Tube (K861626) received a 510(k) decision of Substantially Equivalent on June 2, 1986, 41 days after the submission was received.
What is the product code of K861626?
The FDA product code is FPK – Tubing, Fluid Delivery, a Class II (moderate risk) device regulated under 21 CFR 880.5440.