FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OCHSNER & MICRON FABRIC PATCH
K Number: K881508
·
Decision May 25, 1988
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
89
Applicant Total
16
Review Days
44
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Basic Information
- Device Name
- OCHSNER & MICRON FABRIC PATCH
- K Number
- K881508
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3470
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Intervascular, Inc.
- Date Received
- April 11, 1988
- Decision Date
- May 25, 1988
- Product Code
- DXZ
- 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 |
|---|---|---|---|
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | FDA class 2 | Cardiovascular |
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Other Clearances by Intervascular, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K990800 | INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS | Jan 8, 2001 | Substantially Equivalent |
| K984294 | MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES | Feb 22, 1999 | Substantially Equivalent |
| K983819 | INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN | Nov 24, 1998 | Substantially Equivalent |
| K970843 | INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES | Jun 5, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K964625 | HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES | May 5, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K921659 | ULTRA LOW POROSITY DACRON WOVEN PATCH | Nov 25, 1992 | Unknown |
| K913143 | OCHSNER ULP BIFURCATION VASCULAR PROTHESIS | Oct 23, 1991 | Substantially Equivalent |
| K912911 | LOW POROSITY (LP) VASCULAR PROSTHESIS | Sep 23, 1991 | Substantially Equivalent |
| K905269 | OCHSNER 500 VASCULAR PROSTHESIS | Apr 2, 1991 | Substantially Equivalent |
| K905270 | OCHSNER 50 VASCULAR PROSTHESIS | Feb 15, 1991 | Substantially Equivalent |