FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BI-DIRECTIONAL TUNNELER
K Number: K991027
·
Decision Apr 22, 1999
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
187
Applicant Total
29
Review Days
24
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Basic Information
- Device Name
- BI-DIRECTIONAL TUNNELER
- K Number
- K991027
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.3450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Impra, Inc.
- Date Received
- March 29, 1999
- Decision Date
- April 22, 1999
- Product Code
- DSY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | FDA class 2 | Cardiovascular |
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Other Clearances by Impra, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K004012 | IMPRA CARBOFLO EPTFE VASCULAR GRAFTS | May 14, 2001 | Substantially Equivalent |
| K004011 | IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS | Mar 27, 2001 | Substantially Equivalent |
| K983769 | DISTAFLO BYPASS GRAFT | Dec 15, 1998 | Substantially Equivalent |
| K983861 | DISTAFLO BYPASS GRAFT | Nov 24, 1998 | Substantially Equivalent |
| K983064 | IMPRA HIGH POROSITY GRAFT | Nov 19, 1998 | Substantially Equivalent |
| K981076 | VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT | May 7, 1998 | Substantially Equivalent |
| K981079 | VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT | May 7, 1998 | Substantially Equivalent |
| K971192 | IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT | Apr 15, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K964877 | IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT | Mar 20, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K964197 | IMPRA CARBOFLO EPTFE VASCULAR GRAFT | Jan 2, 1997 | Substantially Equivalent |