FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHASE SUCKER
K Number: K971022
·
Decision Apr 17, 1997
Classifications
1
FEI Numbers
193
Registration Numbers
193
Same Product Code
86
Applicant Total
27
Review Days
28
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Basic Information
- Device Name
- CHASE SUCKER
- K Number
- K971022
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Chase Medical, Inc.
- Date Received
- March 20, 1997
- Decision Date
- April 17, 1997
- Product Code
- GCX
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | FDA class 2 | General Hospital |
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Other Clearances by Chase Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K032531 | CHASE CARDIAC ANALYSIS SYSTEM | Feb 2, 2004 | Substantially Equivalent |
| K022093 | CHASE CARDIOVASCULAR PATCH KIT | Sep 20, 2002 | Substantially Equivalent |
| K021129 | CHARE CARIOVASCULAR PATCH | Jun 3, 2002 | Substantially Equivalent |
| K020233 | CHASE CARDIOVASCULAR PATCH KIT | Mar 14, 2002 | Substantially Equivalent |
| K020132 | CHASE CARDIOVASCULAR PATCH KIT | Feb 26, 2002 | Substantially Equivalent |
| K012248 | CHASE CARDIOVASCULAR PATCH | Aug 10, 2001 | Substantially Equivalent |
| K003467 | CHASE CARDIOVASCULAR PATCH | Jan 29, 2001 | Substantially Equivalent |
| K001662 | CHASE CARDIOVASCULAR PATCH | Aug 2, 2000 | Substantially Equivalent |
| K972993 | CHASE FEMORAL ACCESS CANNULATION SET | Mar 31, 1998 | Substantially Equivalent |
| K974568 | CHASE ANASTOMOSIS VISUALIZATION DEVICE | Jan 6, 1998 | Substantially Equivalent |