FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
10 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON
K Number: K892797
·
Decision Sep 20, 1989
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
161
Applicant Total
57
Review Days
156
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Basic Information
- Device Name
- 10 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON
- K Number
- K892797
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3535
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Kontron Instruments, Inc.
- Date Received
- April 17, 1989
- Decision Date
- September 20, 1989
- Product Code
- DSP
- 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 |
|---|---|---|---|
| DSP | System, Balloon, Intra-Aortic And Control | FDA class 2 | Cardiovascular |
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Other Clearances by Kontron Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K932268 | MODIFICATIONS TO INTRA-AORTIC BALLOONS | Dec 15, 1993 | Substantially Equivalent |
| K925248 | MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS | Sep 27, 1993 | Substantially Equivalent |
| K923603 | INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION | Mar 8, 1993 | Substantially Equivalent |
| K905313 | KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II | Jun 19, 1991 | Substantially Equivalent |
| K903344 | 9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM) | Jan 15, 1991 | Substantially Equivalent |
| K896437 | KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM | Dec 3, 1990 | Substantially Equivalent |
| K892222 | 9.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON | Sep 14, 1990 | Substantially Equivalent |
| K882955 | SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283 | Jan 26, 1990 | Substantially Equivalent |
| K896386 | MINIMON 7133B PATIENT MONITOR | Dec 13, 1989 | Substantially Equivalent |
| K896417 | KONTRON KOLORMON 7250 PATIENT MONITOR | Dec 12, 1989 | Substantially Equivalent |