FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CORE AND COIL ASSEMBLY GUIDEWIRE
K Number: K970994
·
Decision Mar 25, 1997
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
2
Applicant Total
42
Review Days
6
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Basic Information
- Device Name
- CORE AND COIL ASSEMBLY GUIDEWIRE
- K Number
- K970994
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lake Region Mfg., Inc.
- Date Received
- March 19, 1997
- Decision Date
- March 25, 1997
- Product Code
- EZB
- 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 |
|---|---|---|---|
| EZB | Stylet For Catheter, Gastro-Urology | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EZB), ordered by most recent decision date.
APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
GUIDE WIRE
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
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| K080144 | MANDREL GUIDEWIRES OR M-WIRES | Feb 26, 2008 | Substantially Equivalent |
| K073655 | PEGASUS STEERABLE (PTCA) GUIDEWIRE | Jan 28, 2008 | Substantially Equivalent |
| K060454 | TITAN GUIDEWIRE | Mar 24, 2006 | Substantially Equivalent |
| K052347 | TITAN STEERABLE (PTCA) GUIDEWIRE | Feb 17, 2006 | Substantially Equivalent |
| K042338 | CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE | Sep 16, 2004 | Substantially Equivalent |
| K041624 | PTCA STEERABLE HYDROPHILIC GUIDEWIRE | Jul 16, 2004 | Substantially Equivalent |
| K040825 | LAKE REGION HYDROPHILIC GUIDEWIRE | May 17, 2004 | Substantially Equivalent |