FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
ENDOCARDIAL SCREW-IN LEAD MODEL 1028T
K Number: K902147
·
Decision Jul 17, 1990
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
486
Applicant Total
96
Review Days
63
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Basic Information
- Device Name
- ENDOCARDIAL SCREW-IN LEAD MODEL 1028T
- K Number
- K902147
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Pacesetter Systems
- Date Received
- May 15, 1990
- Decision Date
- July 17, 1990
- Product Code
- DTB
- 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 |
|---|---|---|---|
| DTB | Permanent Pacemaker Electrode | FDA class 3 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DTB), ordered by most recent decision date.
BIOTRONIK ENDOCARDIAL PACING LEADS
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PERMANENT PACING LEAD, MODEL PY2
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PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU
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MODEL 5071 MYOCARDIAL PACING LEAD
FDA 510(k)
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·Cardiovascular
MODEL 4951M MYOCARDIAL UNIPOLAR LEAD
FDA 510(k)
FDA Class 3
·Cardiovascular
ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP
FDA 510(k)
FDA Class 3
·Cardiovascular
Other Clearances by Pacesetter Systems
| K Number | Device Name | ||
|---|---|---|---|
| K910924 | ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE | Aug 28, 1991 | 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 |
| K874205 | ENDOCARDIAL SCREW-IN LEAD, MODEL 1018T | Feb 2, 1988 | Substantially Equivalent |