FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP
K Number: K983866
·
Decision Jan 6, 2000
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
161
Applicant Total
20
Review Days
430
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Basic Information
- Device Name
- BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP
- K Number
- K983866
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3535
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Belmont Instrument Corp.
- Date Received
- November 2, 1998
- Decision Date
- January 6, 2000
- 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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| K090089 | BELMONT HYPERTHERMIA PUMP | Feb 12, 2009 | Substantially Equivalent |
| K070654 | HYPERTHERMIA PUMP | Jun 8, 2007 | Substantially Equivalent |
| K062774 | BELMONT BUDDY PLUS FLUID WARMER | Oct 19, 2006 | Substantially Equivalent |
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| K032778 | LARGE VOLUME FLUID RESERVOIR | Sep 22, 2003 | Substantially Equivalent |
| K032674 | BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000 | Sep 16, 2003 | Substantially Equivalent |