Connectors
FDA 510(k) K770596 · Abco Dealers, Inc.
510(k) numberK770596
Submission
- Device name
- Connectors
- Applicant
- Abco Dealers, Inc.
Mchenry, IL, US - Received
- March 28, 1977
- Decision date
- June 20, 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 |
|---|---|---|
| K905025 | Digital Thermometer KitsFLL · Traditional | 02/07/1991SE |
| K882304 | Digital Thermometer Sheaths (Oral and Rectal)FLL · Traditional | 07/12/1988SE |
| K880892 | Blood Collecting Needle and HoldersFMI · Traditional | 04/21/1988SE |
| K880894 | Allergist SyringesFMF · Traditional | 03/31/1988SE |
| K872875 | Stretch Gauze BandagesNAD · Traditional | 09/04/1987SE |
| K872874 | Microscope Cover GlassesKES · Traditional | 08/10/1987SE |
| K872797 | Non-Skid Shoe CoversFXP · Traditional | 08/04/1987SE |
| K871465 | Thermometer SheathsFLL · Traditional | 05/11/1987SE |
| K862726 | Disposable Shoe Covers and Nurses CapsFXP · Traditional | 08/01/1986SE |
| K862111 | Armboards, Reusable and Disposable · Traditional | 07/08/1986SE |
Questions and answers
When was Connectors cleared by the FDA?
Connectors (K770596) received a 510(k) decision of Substantially Equivalent on June 20, 1977, 84 days after the submission was received.
What is the product code of K770596?
The FDA product code is FPK – Tubing, Fluid Delivery, a Class II (moderate risk) device regulated under 21 CFR 880.5440.