FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VESSEL DILATORS
K Number: K910502
·
Decision Apr 29, 1991
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
2
Applicant Total
36
Review Days
83
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Basic Information
- Device Name
- VESSEL DILATORS
- K Number
- K910502
- 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
- February 5, 1991
- Decision Date
- April 29, 1991
- Product Code
- FKA
- 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 |
|---|---|---|---|
| FKA | Dilator, Vessel | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FKA), ordered by most recent decision date.
SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VAS-CATH DUALATOR(TM) VESSEL DILATOR
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 |