FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
ENDOLUMINAL ACCESS TUBE
K Number: K941228
·
Decision Sep 27, 1995
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
26
Review Days
561
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Basic Information
- Device Name
- ENDOLUMINAL ACCESS TUBE
- K Number
- K941228
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Med Institute, Inc.
- Date Received
- March 15, 1994
- Decision Date
- September 27, 1995
- Product Code
- KNT
- 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | FDA class 2 | Gastroenterology, Urology |
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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 |
| K981061 | INTRAVASCULAR RETRIEVAL DEVICE | May 26, 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 |
| 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 |