T-Connectors 014500/014501/014502/014503-120
FDA 510(k) K870912 · Clinical Connections, Inc.
510(k) numberK870912
Submission
- Device name
- T-Connectors 014500/014501/014502/014503-120
- Applicant
- Clinical Connections, Inc.
Orrville, OH, US - Received
- March 6, 1987
- Decision date
- March 17, 1987
- 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 |
|---|---|---|
| K884435 | Resubmitted 1,3 & 4 Way Stopcocks, Various PartsFMG · Traditional | 11/08/1988SE |
| K871540 | Swivel Connectors #014452/#014453/#014459-120FPK · Traditional | 04/30/1987SE |
| K870325 | #014160-TAB Tubing Rotator AdaptorDTL · Traditional | 04/27/1987SE |
| K870477 | Device Connectors #000299-000 3/8 X 3/8 X 3/8 Y · Traditional | 04/03/1987SE |
| K870913 | Injection Site #014456-120FPA · Traditional | 03/17/1987SE |
| K870324 | #014460-120 3-WAY & #014461-120 4-WAY StopcockFMG · Traditional | 03/13/1987SE |
| K870394 | Hydrophobic #6194418/HYDRAPHILIC #6104418 FiltersFIB · Traditional | 03/03/1987SE |
| K870073 | Manifold Swivel Rotator Models 014320 & 014321-TABDTL · Traditional | 02/20/1987SE |
| K870326 | Various Luer and Tubing FittingsFPK · Traditional | 02/10/1987SE |
Questions and answers
When was T-Connectors 014500/014501/014502/014503-120 cleared by the FDA?
T-Connectors 014500/014501/014502/014503-120 (K870912) received a 510(k) decision of Substantially Equivalent on March 17, 1987, 11 days after the submission was received.
What is the product code of K870912?
The FDA product code is FPK – Tubing, Fluid Delivery, a Class II (moderate risk) device regulated under 21 CFR 880.5440.