FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLEXIBLE DILATING SHEATH
K Number: K945586
·
Decision Apr 4, 1997
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
103
Applicant Total
26
Review Days
872
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- FLEXIBLE DILATING SHEATH
- K Number
- K945586
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Med Institute, Inc.
- Date Received
- November 14, 1994
- Decision Date
- April 4, 1997
- Product Code
- DRE
- 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 |
|---|---|---|---|
| DRE | Dilator, Vessel, For Percutaneous Catheterization | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRE), ordered by most recent decision date.
ProtekDilate Vascular Access Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
VersaCross Connect Transseptal Dilator
FDA 510(k)
FDA Class 2
·Cardiovascular
Micro Ace Gold Advanced Micro Access System
FDA 510(k)
FDA Class 2
·Cardiovascular
VersaCross Connect Transseptal Dilator
FDA 510(k)
FDA Class 2
·Cardiovascular
VersaCross Connect Transseptal Dilator
FDA 510(k)
FDA Class 2
·Cardiovascular
Micro Ace Advanced Micro Access System
FDA 510(k)
FDA Class 2
·Cardiovascular
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 |
| 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 |