FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHASE CARDIOVASCULAR PATCH
K Number: K001662
·
Decision Aug 2, 2000
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
90
Applicant Total
27
Review Days
63
Basic Information
- Device Name
- CHASE CARDIOVASCULAR PATCH
- K Number
- K001662
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3470
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CHASE MEDICAL, INC.
- Date Received
- May 31, 2000
- Decision Date
- August 2, 2000
- Product Code
- DXZ
- 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 |
|---|---|---|---|
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | FDA class 2 | Cardiovascular |
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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 |
| K972993 | CHASE FEMORAL ACCESS CANNULATION SET | Mar 31, 1998 | Substantially Equivalent |
| K974568 | CHASE ANASTOMOSIS VISUALIZATION DEVICE | Jan 6, 1998 | Substantially Equivalent |
| K971013 | CHASE TEMPERATURE PROBE | Oct 28, 1997 | Substantially Equivalent |