FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
MICROPULSE 22S PACEMAKER
K Number: K780780
·
Decision Jun 30, 1978
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
460
Applicant Total
13
Review Days
50
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Basic Information
- Device Name
- MICROPULSE 22S PACEMAKER
- K Number
- K780780
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Edwards Pacemaker Systems
- Date Received
- May 11, 1978
- Decision Date
- June 30, 1978
- 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
FDA 510(k)
FDA Class 3
·Cardiovascular
OPUS S MODEL 4121 AND 4124 PACEMAKERS
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FDA Class 3
·Cardiovascular
PIKOS LP 01, PIKOS LP E01
FDA 510(k)
FDA Class 3
·Cardiovascular
ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)
FDA 510(k)
FDA Class 3
·Cardiovascular
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 Edwards Pacemaker Systems
| K Number | Device Name | ||
|---|---|---|---|
| K791751 | EDWARDS PACEMAKER 30 UNIPOLAR GENERATOR | Sep 26, 1979 | Substantially Equivalent |
| K790452 | 28 UNIPOLAR AND BIPOLAR PULSE GENERATORS | May 8, 1979 | Substantially Equivalent |
| K781111 | LEAD CONVERSION KIT, MODEL 341 | Aug 31, 1978 | Substantially Equivalent |
| K781144 | ANALYZER, PACER SYSTEM, PSA-5 | Aug 23, 1978 | Substantially Equivalent |
| K781042 | PROLITH 23S PACEMAKER | Jul 27, 1978 | Substantially Equivalent |
| K780238 | PACEMAKER, PROLITH 23U. PULSE GENERATOR | Mar 15, 1978 | Substantially Equivalent |
| K780091 | MICROPULSE 22U | Jan 30, 1978 | Substantially Equivalent |
| K771987 | MICROPULSE 26U PULSE GENERATOR | Nov 2, 1977 | Substantially Equivalent |
| K770657 | GENERATOR, PULSE, CARDIAC 2LU | Apr 26, 1977 | Substantially Equivalent |
| K770656 | GENERATOR, PULSE, CARDIAC 20U | Apr 26, 1977 | Substantially Equivalent |