VASCULAR ACCESS SYSTEM
FDA 510(k) clearance K810114 · decided 1981-03-26
Clearance details
- K-number
- K810114
- Device name
- VASCULAR ACCESS SYSTEM
- Applicant
- Bentley Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-12-15
- Decision date
- 1981-03-26
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- FIQ
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA (K892887) | Akcess Medical Products, Inc. | 1989-05-15 |
| S-100 ALLEN-BROWN SHUNT (K892663) | Akcess Medical Products, Inc. | 1989-05-04 |
| SAF-T-SHUNT, S-300 SERIES (K892666) | Akcess Medical Products, Inc. | 1989-05-04 |
| PEDIATRIC SIZED HEMOCATH CATHETER (K844692) | Quinton, Inc. | 1985-01-18 |
| PLUME FISTULA NEEDLE (K841791) | Hospal Medical Corp. | 1984-07-09 |
| HEMOFILTRATION CATHETER HF-100 (K840322) | Vas-Cath of Canada , Ltd. | 1984-04-24 |
| HEMOCATH (K840415) | Quinton, Inc. | 1984-04-20 |
| PARALLEL DUAL LUMEN SUBCLAVIAN CANNULA (K834358) | Vas-Cath of Canada , Ltd. | 1984-04-02 |
| HEMASITE/RENALOY -VASCULAR ACCESS SHUNT (K840436) | Renal Systems, Inc. | 1984-02-21 |
| RENALLOY HEMASITE VASCULAR ACCESS SHUNT (K833622) | Renal Systems, Inc. | 1983-11-29 |
| HEMOCLAV VENOUS CATHETER (K831801) | Exo, Inc. | 1983-07-07 |
| SINGLE NEEDLE SUBCLAVIAN VEIN ACCESS (K831401) | Med-West, Inc. | 1983-06-03 |
Recalls involving this device
No recalls on record reference this clearance.