FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GUIDEWIRE
K Number: K982559
·
Decision Feb 1, 1999
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
14
Review Days
193
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Basic Information
- Device Name
- GUIDEWIRE
- K Number
- K982559
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Galt Medical Corp.
- Date Received
- July 23, 1998
- Decision Date
- February 1, 1999
- Product Code
- DQX
- 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 |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | FDA class 2 | Cardiovascular |
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| K071330 | GALTSTICK INTRODUCER SYSTEM | Oct 31, 2007 | Substantially Equivalent |
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