Centurion Kleen-Needle System I.V. Extension Sets
FDA 510(k) K910906 · Tri-State Hospital Supply Corp.
510(k) numberK910906
Submission
- Device name
- Centurion Kleen-Needle System I.V. Extension Sets
- Applicant
- Tri-State Hospital Supply Corp.
Howell, MI, US - Received
- March 5, 1991
- Decision date
- April 1, 1991
- 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 |
|---|---|---|
| K080448 | Centurion Protective Restraint, SCR SeriesFMQ · Traditional | 08/28/2008SE |
| K080524 | Centurion Sorbaview OTCNAD · Traditional | 04/23/2008SE |
| K942353 | Centurion Umbilical CatheterFOS · Traditional | 08/15/1995SE |
| K945977 | Centurion(R) Site Guard(R) Transparent Dressing/Transpaent Film DressingMGP · Traditional | 03/29/1995SE |
| K931748 | Centlurion Disp Steri Dental/Hygiene Pack/TraysLJT · Traditional | 02/25/1994SESK |
| K935491 | Centurion Mogen Clamp/Circumcision (Ster/Non Ster)HFX · Traditional | 02/17/1994SE |
| K923812 | Centurion Disposable InstrumentsMDM · Traditional | 12/17/1992SE |
| K897100 | Centurion Vaginal SpeculumHIC · Traditional | 03/16/1990SE |
| K896320 | Centurion Kleen-Needle SystemFMI · Traditional | 01/11/1990SE |
| K893647 | Copolyester Film DressingKGN · Traditional | 10/16/1989SE |
Questions and answers
When was Centurion Kleen-Needle System I.V. Extension Sets cleared by the FDA?
Centurion Kleen-Needle System I.V. Extension Sets (K910906) received a 510(k) decision of Substantially Equivalent on April 1, 1991, 27 days after the submission was received.
What is the product code of K910906?
The FDA product code is FPK – Tubing, Fluid Delivery, a Class II (moderate risk) device regulated under 21 CFR 880.5440.