Vented Diakysate Port Ccap, Red Pliable Vinyl - Dayspring Medical Part No, DPC101VS
FDA 510(k) K991005 · Dayspring Medical, Inc.
510(k) numberK991005
Submission
- Device name
- Vented Diakysate Port Ccap, Red Pliable Vinyl - Dayspring Medical Part No, DPC101VS
- Applicant
- Dayspring Medical, Inc.
Boulder, CO, US - Received
- March 25, 1999
- Decision date
- June 22, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LLB – System, Blood, Extracorporeal And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code LLB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K831404 | Blood Monitor BMM 10-4LLB · Traditional | Gambro, Inc. | 04/25/1984SE |
More from Gambro, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K991003 | Pump Segment Rinse Line W/ Slip-On Connector, Pump Segment Rinse Line W/ Luer-Lock…FKY · Traditional | 06/09/1999SE |
| 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 Vented Diakysate Port Ccap, Red Pliable Vinyl - Dayspring Medical Part No, DPC101VS cleared by the FDA?
Vented Diakysate Port Ccap, Red Pliable Vinyl - Dayspring Medical Part No, DPC101VS (K991005) received a 510(k) decision of Substantially Equivalent on June 22, 1999, 89 days after the submission was received.
What is the product code of K991005?
The FDA product code is LLB – System, Blood, Extracorporeal And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.5820.