FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
MDL-201A & T DL-201A PULSE GENERATOR
K Number: K790428
·
Decision Aug 10, 1979
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
460
Applicant Total
96
Review Days
162
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Basic Information
- Device Name
- MDL-201A & T DL-201A PULSE GENERATOR
- K Number
- K790428
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Pacesetter Systems
- Date Received
- March 1, 1979
- Decision Date
- August 10, 1979
- Product Code
- DXY
- 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 |
|---|---|---|---|
| DXY | Implantable Pacemaker Pulse-Generator | FDA class 3 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXY), ordered by most recent decision date.
PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
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FDA Class 3
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OPUS S MODEL 4121 AND 4124 PACEMAKERS
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PIKOS LP 01, PIKOS LP E01
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FDA Class 3
·Cardiovascular
ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)
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FDA Class 3
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MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
FDA 510(k)
FDA Class 3
·Cardiovascular
MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS
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 |
| 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 |