FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFUSION SETS #'S 124 & 142 PERSONAL
K Number: K831445
·
Decision Sep 12, 1983
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
96
Review Days
130
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Basic Information
- Device Name
- INFUSION SETS #'S 124 & 142 PERSONAL
- K Number
- K831445
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Pacesetter Systems
- Date Received
- May 5, 1983
- Decision Date
- September 12, 1983
- Product Code
- FPA
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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Other Clearances by Pacesetter Systems
| K Number | Device Name | ||
|---|---|---|---|
| K910924 | ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE | Aug 28, 1991 | Substantially Equivalent |
| K902147 | ENDOCARDIAL SCREW-IN LEAD MODEL 1028T | Jul 17, 1990 | Substantially Equivalent |
| K900512 | SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS | Jun 25, 1990 | Substantially Equivalent |
| K900550 | FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T | Apr 20, 1990 | Substantially Equivalent |
| K895447 | ENDOCARDIAL SCREW-IN LEAD MODEL 1020T | Dec 20, 1989 | Substantially Equivalent |
| K891905 | CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE | Jun 5, 1989 | Substantially Equivalent |
| K885267 | VS-1 MODEL NUMBER 251K PULSE GENERATOR | Mar 28, 1989 | Substantially Equivalent |
| K890547 | SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS | Mar 22, 1989 | Substantially Equivalent |
| K884733 | AFP MODEL 262T PULSE GENERATOR | Feb 10, 1989 | Substantially Equivalent |
| K883087 | PROLOG MP 658M PULSE GENERATOR | Sep 14, 1988 | Substantially Equivalent |