FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA
K Number: K892887
·
Decision May 15, 1989
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
22
Applicant Total
36
Review Days
25
Basic Information
- Device Name
- ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA
- K Number
- K892887
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Akcess Medical Products, Inc.
- Date Received
- April 20, 1989
- Decision Date
- May 15, 1989
- Product Code
- FIQ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FIQ | Cannula, A-V Shunt | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FIQ), ordered by most recent decision date.
SAF-T-SHUNT, S-300 SERIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
S-100 ALLEN-BROWN SHUNT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PEDIATRIC SIZED HEMOCATH CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PLUME FISTULA NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEMOFILTRATION CATHETER HF-100
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEMOCATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Akcess Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K926374 | SILICONE CATHETER REPAIR KITS | Oct 7, 1994 | Unknown |
| K925819 | AKCESS0CATH KIT | Aug 2, 1994 | Substantially Equivalent |
| K925818 | AKCESS-CATH | Apr 5, 1994 | Substantially Equivalent |
| K930630 | RIGHT ATRIAL CATHETER | Feb 7, 1994 | Substantially Equivalent for Some Indications |
| K920634 | SPLITTABLE SHEATH INTRODUCER SET | Jan 14, 1994 | Substantially Equivalent |
| K931120 | COAXIAL ACUTE CATHETER | Jan 14, 1994 | Substantially Equivalent |
| K914936 | CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET | Apr 23, 1992 | Unknown |
| K920331 | RIGHT ATRIAL CATHETER KITS | Apr 22, 1992 | Unknown |
| K914826 | AKCESS-CATH KIT | Apr 10, 1992 | Unknown |
| K915215 | CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS | Mar 27, 1992 | Unknown |