510(k) K864629
- Device
- MODIFIED DUAL LUMEN NEEDLE
- Applicant
- QUINTON, INC.
- 510(k) number
- K864629
- Product code
- LBW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-12-16
- Date received
- 1986-11-25
- Regulation
- 876.5540
- Classification name
- Set, Dialysis, Single Needle (co-axial Flow)
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY-LEE DONOGHUE
- Address
- 2121 Terry Ave. Seattle WA US 98121 98121
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LBW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K904433 | DUAL LUMEN NEEDLES | Akcess Medical Products, Inc. | 1990-11-23 |
| K860515 | DUAL LUMEN NEEDLE (PRODUCT CHANGE) | Quinton, Inc. | 1986-03-04 |
| K820859 | COAXIAL DUAL FLOW CATHETER | Terumo Medical Corp. | 1982-04-16 |
| K801968 | HEMOCATH I KIDNEY DIALYSIS CATHETER | Medical Components, Inc. | 1980-09-26 |
Legacy Summary#
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FDA Review#
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