FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INTRAVASCULAR RETRIEVAL DEVICE
K Number: K981061
·
Decision May 26, 1998
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
4
Applicant Total
26
Review Days
64
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Basic Information
- Device Name
- INTRAVASCULAR RETRIEVAL DEVICE
- K Number
- K981061
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Med Institute, Inc.
- Date Received
- March 23, 1998
- Decision Date
- May 26, 1998
- Product Code
- GCC
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GCC | Dilator, Catheter | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GCC), ordered by most recent decision date.
BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BYRD STAINLESS STEEL DILATOR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BYRD EXTRACTOR SET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VAN-TEC FASCIAL DILATOR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Med Institute, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K990034 | WILSON-COOK COLONIC Z-STENT | Apr 17, 2000 | Substantially Equivalent |
| K982507 | MINI POLYURETHANE CATHETER | Sep 16, 1998 | Substantially Equivalent |
| K964001 | SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM | Apr 17, 1998 | Substantially Equivalent |
| K971140 | VITAL-PORT INFUSION PAL | Nov 17, 1997 | Substantially Equivalent |
| K970442 | TARGET VITAL-PORT VASCULAR ACCESS SYSTEM | Apr 30, 1997 | Substantially Equivalent |
| K945586 | FLEXIBLE DILATING SHEATH | Apr 4, 1997 | Substantially Equivalent |
| K960698 | NON-CORING NEEDLE | Apr 15, 1996 | Substantially Equivalent |
| K941228 | ENDOLUMINAL ACCESS TUBE | Sep 27, 1995 | Unknown |
| K951077 | VITAL-PORT PETIET POLYSULFONE VASCULAR ACCESS SYSTEM | Jul 31, 1995 | Substantially Equivalent |
| K951076 | VITAL-PORT PETITE DUAL VASCULAR ACCESS SYSTEM | Jun 13, 1995 | Substantially Equivalent |