Pump Segment Rinse Line W/ Slip-On Connector, Pump Segment Rinse Line W/ Luer-Lock Connector, T-Connector, Short, W/ Sli
FDA 510(k) K991003 · Dayspring Medical, Inc.
510(k) numberK991003
Submission
- Device name
- Pump Segment Rinse Line W/ Slip-On Connector, Pump Segment Rinse Line W/ Luer-Lock Connector, T-Connector, Short, W/ Sli
- Applicant
- Dayspring Medical, Inc.
Boulder, CO, US - Received
- March 25, 1999
- Decision date
- June 9, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FKY – Connector, Tubing, Dialysate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FKY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K862722 | Tubing Connector #10-810-60 100/PKG Non-SterileFKY · Traditional | Mercury Enterprises, Inc. | 08/11/1986SE |
| K830002 | Capd Color-Guard System PrepkitFKY · Traditional | Abbott Laboratories | 03/11/1983SE |
| K771428 | Tenckhoff Peritoneal Tubing Adapt.FKY · Traditional | Quinton, Inc. | 10/18/1977SE |
More from Quinton, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K991005 | Vented Diakysate Port Ccap, Red Pliable Vinyl - Dayspring Medical Part No, DPC101VSLLB · Traditional | 06/22/1999SE |
| K961039 | Bllod Port Cap, Dialysate Port Cap, Vented Dialysate Port Cap with Red Pliable VinylFJI · Traditional | 09/12/1996SE |
| K961040 | Blood Port Cap, Dialysate Port Cap, Red Hard PlasticFJI · Traditional | 06/11/1996SE |
| K961026 | Blood Port Cap, Luer-Lock Fitting, Dayspring Medical Part No. BPC252LLFJI · Traditional | 06/10/1996SE |
Questions and answers
When was Pump Segment Rinse Line W/ Slip-On Connector, Pump Segment Rinse Line W/ Luer-Lock Connector, T-Connector, Short, W/ Sli cleared by the FDA?
Pump Segment Rinse Line W/ Slip-On Connector, Pump Segment Rinse Line W/ Luer-Lock Connector, T-Connector, Short, W/ Sli (K991003) received a 510(k) decision of Substantially Equivalent on June 9, 1999, 76 days after the submission was received.
What is the product code of K991003?
The FDA product code is FKY – Connector, Tubing, Dialysate, a Class II (moderate risk) device regulated under 21 CFR 876.5820.