FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STOCKERT CORONARY PERFUSION CANNULAE
K Number: K022280
·
Decision Oct 11, 2002
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
393
Applicant Total
9
Review Days
88
Basic Information
- Device Name
- STOCKERT CORONARY PERFUSION CANNULAE
- K Number
- K022280
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 870.4210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- STOCKERT INSTRUMENTE GMBH
- Date Received
- July 15, 2002
- Decision Date
- October 11, 2002
- Product Code
- DWF
- 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 |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by STOCKERT INSTRUMENTE GMBH
| K Number | Device Name | ||
|---|---|---|---|
| K042374 | STOCKERT SCP RHYTHM | Sep 23, 2004 | Substantially Equivalent |
| K041558 | STOCKERTIR PURGE CONTROL (APC) SYSTEM | Jul 2, 2004 | Substantially Equivalent |
| K032213 | STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP | Aug 29, 2003 | Substantially Equivalent |
| K023622 | STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35 | Nov 21, 2002 | Substantially Equivalent |
| K022321 | STOCKERT V172-28 VENOUS FEMORAL CANNULA | Oct 9, 2002 | Substantially Equivalent |
| K020571 | STOCKERT CENTRIFUGAL PUMP CONSOLE | Sep 23, 2002 | Substantially Equivalent |
| K011838 | CENTRIFUGAL PUMP | Feb 5, 2002 | Substantially Equivalent |
| K011088 | SIII ALARM AMPLIFIER | May 2, 2001 | Substantially Equivalent |