Monitoring Lines & Fluid Admin.
FDA 510(k) K771387 · Norton Performance Plastics Corp.
510(k) numberK771387
Submission
- Device name
- Monitoring Lines & Fluid Admin.
- Applicant
- Norton Performance Plastics Corp.
Walker, MI, US - Received
- July 27, 1977
- Decision date
- August 22, 1977
- 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 |
|---|---|---|
| K853791 | Norton Cardioplegic Quick Cooling Coil 421738-000DTR · Traditional | 12/09/1985SE |
| K852914 | Angiographic, Wedge Press, Dual Thermod & InfusionDQY · Traditional | 09/25/1985SE |
| K851299 | Correct FloFPA · Traditional | 05/07/1985SE |
| K842858 | Fluid Administration Line W/Spike 14-923FPA · Traditional | 09/11/1984SE |
| K841828 | Central Venous Catheter W/Big-GardDQY · Traditional | 07/13/1984SE |
| K840240 | Microfuse Intravenous Catheter SetDQY · Traditional | 04/17/1984SE |
| K831587 | Temp. Repair Kit-Dual Lumen CatheterLJS · Traditional | 10/19/1983SE |
| K831698 | Disposable Pressure TRANSDUCER#14004195DRS · Traditional | 08/11/1983SE |
| K830788 | Central Vein Catherization KIT-14-690-DQO · Traditional | 04/30/1983SE |
| K830813 | French Percutaneous Sheath IntroducerDYB · Traditional | 04/28/1983SE |
Questions and answers
When was Monitoring Lines & Fluid Admin. cleared by the FDA?
Monitoring Lines & Fluid Admin. (K771387) received a 510(k) decision of Substantially Equivalent on August 22, 1977, 26 days after the submission was received.
What is the product code of K771387?
The FDA product code is FPK – Tubing, Fluid Delivery, a Class II (moderate risk) device regulated under 21 CFR 880.5440.