FDA 510(k)
FDA class 3
Substantially Equivalent - Subject to Tracking Reg.
🇺🇸 United States
CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD
K Number: K955550
·
Decision Jun 19, 1996
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
486
Applicant Total
211
Review Days
197
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Basic Information
- Device Name
- CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD
- K Number
- K955550
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Applicant
- Intermedics, Inc.
- Date Received
- December 5, 1995
- Decision Date
- June 19, 1996
- 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
FDA 510(k)
FDA Class 3
·Cardiovascular
MODEL 5071 MYOCARDIAL PACING LEAD
FDA 510(k)
FDA Class 3
·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 Intermedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954610 | MODEL 430-07 ENDOCARDIAL PACING LEAD | Dec 16, 1996 | Substantially Equivalent - Subject to Tracking & PMS |
| K955122 | INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD | Nov 4, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K962174 | BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07) | Aug 21, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K960281 | IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY | Jun 18, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K954719 | INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD | Feb 27, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K933278 | INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 | Mar 15, 1995 | Substantially Equivalent |
| K922042 | CARDIFIX ENDOCARDIAL PACING LEAD | Apr 29, 1993 | Unknown |
| K922972 | MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD | Jan 22, 1993 | Unknown |
| K920530 | INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG | Mar 17, 1992 | Substantially Equivalent |
| K912235 | MODELS 432-03 & 433-03 IMPLANT ENDOCARD PAC LEAD | Sep 18, 1991 | Substantially Equivalent |