FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PMS PERCUTANEOUS PUNCTURE NEEDLE
K Number: K854941
·
Decision Apr 16, 1986
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
19
Review Days
127
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Basic Information
- Device Name
- PMS PERCUTANEOUS PUNCTURE NEEDLE
- K Number
- K854941
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Professional Medical Services
- Date Received
- December 10, 1985
- Decision Date
- April 16, 1986
- Product Code
- DYB
- 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 |
|---|---|---|---|
| DYB | Introducer, Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by Professional Medical Services
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| 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 |