FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMP DIRECT VASCULAR MONITORING SYSTEM
K Number: K792646
·
Decision Feb 11, 1980
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
74
Applicant Total
30
Review Days
52
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Basic Information
- Device Name
- AMP DIRECT VASCULAR MONITORING SYSTEM
- K Number
- K792646
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- American Medical Products, Inc.
- Date Received
- December 21, 1979
- Decision Date
- February 11, 1980
- Product Code
- KRH
- 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 |
|---|---|---|---|
| KRH | Ring, Annuloplasty | FDA class 2 | Cardiovascular |
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Other Clearances by American Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K922290 | SINGLE-STEP PREGNANCY, HCG TEST | Jul 9, 1992 | Substantially Equivalent |
| K862221 | E-Z CLEAN | Sep 12, 1986 | Substantially Equivalent |
| K861251 | AMP CLOSED URINARY DRAINAGE BAG, 1011 & 1011N | Apr 17, 1986 | Substantially Equivalent |
| K830881 | AMPERCIDE DISINFECTANT ACCESSORY TO - | Jun 2, 1983 | Substantially Equivalent |
| K823827 | AMP 80/2 OUTFLOW MONITOR MODIFICATION | Mar 17, 1983 | Substantially Equivalent |
| K822545 | CCPD CYCLER SET W/5 PRONGED CONNECTOR | Oct 13, 1982 | Substantially Equivalent |
| K822546 | SAFE LOCK SEALING CAPS | Oct 13, 1982 | Substantially Equivalent |
| K822543 | CAPD SAFE LOCK TRANSFER SET | Oct 13, 1982 | Substantially Equivalent |
| K822551 | AMP CAPD UNISPIKE AMINISTRATION SET | Oct 13, 1982 | Substantially Equivalent |
| K822544 | SAFE LOCK SEALING CAP L | Oct 13, 1982 | Substantially Equivalent |