FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
PULSE GENERATOR, BIPOLAR, PROGRAMMABLE
K Number: K772239
·
Decision Jan 30, 1978
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
460
Applicant Total
76
Review Days
53
Basic Information
- Device Name
- PULSE GENERATOR, BIPOLAR, PROGRAMMABLE
- K Number
- K772239
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- CARDIAC PACEMAKERS, INC.
- Date Received
- December 8, 1977
- Decision Date
- January 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.
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NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01
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Other Clearances by CARDIAC PACEMAKERS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K093969 | ACUITY BREAK-AWAY GUIDE CATHETER | Mar 5, 2010 | Substantially Equivalent |
| K080154 | ACUITY UNIVERSAL CUTTER | Mar 20, 2008 | Substantially Equivalent |
| K934727 | REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER | Jan 10, 1994 | Substantially Equivalent |
| K920601 | ASTRA T2, ASTRA T4, ASTRA T6 | Oct 28, 1992 | Substantially Equivalent |
| K912379 | PDT CARRYALL TRANSMITTER, VARIOUS MODELS | Jun 17, 1991 | Substantially Equivalent |
| K905674 | LEAD STYLET | Jan 30, 1991 | Substantially Equivalent |
| K900498 | MODIFIED BETATRON IV INSULIN INFUSION SYSTEM | Feb 23, 1990 | Substantially Equivalent |
| K894738 | MODEL 6888 LEAD TUNNELER | Sep 13, 1989 | Substantially Equivalent |
| K890785 | ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE | Mar 10, 1989 | Substantially Equivalent |
| K875147 | TORQUE HEX WRENCH | Jan 27, 1988 | Substantially Equivalent |