510(k) K844692
- Device
- PEDIATRIC SIZED HEMOCATH CATHETER
- Applicant
- QUINTON, INC.
- 510(k) number
- K844692
- Product code
- FIQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-01-18
- Date received
- 1984-12-03
- Regulation
- 876.5540
- Classification name
- Cannula, A-v Shunt
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DONALD L ANDERSEN
- Address
- 2121 Terry Ave. Seattle WA US 98121 98121
FDA Registration Numbers#
- 1319639
- 1282497
- 3011237770
- 8020785
- 3013188547
- 3030574705
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FIQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K892887 | ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA | Akcess Medical Products, Inc. | 1989-05-15 |
| K892666 | SAF-T-SHUNT, S-300 SERIES | Akcess Medical Products, Inc. | 1989-05-04 |
| K892663 | S-100 ALLEN-BROWN SHUNT | Akcess Medical Products, Inc. | 1989-05-04 |
| K841791 | PLUME FISTULA NEEDLE | Hospal Medical Corp. | 1984-07-09 |
| K840322 | HEMOFILTRATION CATHETER HF-100 | Vas-Cath of Canada , Ltd. | 1984-04-24 |
| K840415 | HEMOCATH | Quinton, Inc. | 1984-04-20 |
| K834358 | PARALLEL DUAL LUMEN SUBCLAVIAN CANNULA | Vas-Cath of Canada , Ltd. | 1984-04-02 |
| K840436 | HEMASITE/RENALOY -VASCULAR ACCESS SHUNT | Renal Systems, Inc. | 1984-02-21 |
| K833622 | RENALLOY HEMASITE VASCULAR ACCESS SHUNT | Renal Systems, Inc. | 1983-11-29 |
| K831801 | HEMOCLAV VENOUS CATHETER | Exo, Inc. | 1983-07-07 |
| K831440 | SINGLE NEEDLE SUBCLAVIAN VEIN MWI250/260 | Med-West, Inc. | 1983-06-03 |
| K831401 | SINGLE NEEDLE SUBCLAVIAN VEIN ACCESS | Med-West, Inc. | 1983-06-03 |
| K823752 | EXTRACORPOREAL SUBCLAVIAN CATHETER KIT | Extracorporeal Medical Specialities, Inc. | 1983-01-14 |
| K822880 | ARTERIO VENOUS SHUNT CANNULA & ADAPTORS | Renal Systems, Inc. | 1982-10-18 |
| K813237 | HEMASITE VASCULAR ACCESS SHUNT HM-1000 | Renal Systems, Inc. | 1981-11-30 |
Legacy Summary#
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FDA Review#
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