FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT
K Number: K983927
·
Decision Mar 11, 1999
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
11
Applicant Total
3
Review Days
126
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Basic Information
- Device Name
- GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT
- K Number
- K983927
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1370
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arterial Vascular Engineering, Inc.
- Date Received
- November 5, 1998
- Decision Date
- March 11, 1999
- Product Code
- DQT
- 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 |
|---|---|---|---|
| DQT | Occluder, Catheter Tip | FDA class 2 | Cardiovascular |
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