FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIAC CATHETERIZATION PACK
K Number: K840671
·
Decision Mar 12, 1984
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
103
Applicant Total
19
Review Days
20
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Basic Information
- Device Name
- CARDIAC CATHETERIZATION PACK
- K Number
- K840671
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Professional Medical Services
- Date Received
- February 21, 1984
- Decision Date
- March 12, 1984
- Product Code
- DRE
- 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 |
|---|---|---|---|
| DRE | Dilator, Vessel, For Percutaneous Catheterization | FDA class 2 | Cardiovascular |
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Other Clearances by Professional Medical Services
| K Number | Device Name | ||
|---|---|---|---|
| K913094 | DISPOSABLE SLIDE VALVE MANIFOLD | Jan 27, 1992 | Substantially Equivalent |
| K910378 | PRESSURE MONITORING EXTENSION LINE | Apr 22, 1991 | Substantially Equivalent |
| K904508 | CONDOR ANALOG INFLATION SYRINGE | Apr 2, 1991 | Substantially Equivalent |
| K904954 | CONDOR DIGITAL INFLATION SYRINGE | Jan 16, 1991 | Substantially Equivalent |
| K902606 | RADIOPAQUE RULER | Sep 27, 1990 | Substantially Equivalent |
| K884577 | PROCEDURE READY TRAYS | Aug 1, 1989 | Unknown |
| K890471 | PMS ANGIO DRAPE | Feb 27, 1989 | Substantially Equivalent |
| K884497 | CONTROL SYRINGE | Dec 12, 1988 | Substantially Equivalent |
| K872448 | BLOOD CONTAINMENT PACK | Nov 17, 1987 | Substantially Equivalent |
| K864555 | 3 RING ATTACHMENT | Dec 1, 1986 | Substantially Equivalent |