FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP
K Number: K910608
·
Decision Jul 30, 1991
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
486
Applicant Total
18
Review Days
168
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Basic Information
- Device Name
- PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP
- K Number
- K910608
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Biotronik, GmbH & Co.
- Date Received
- February 12, 1991
- Decision Date
- July 30, 1991
- 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
FDA 510(k)
FDA Class 3
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PERMANENT PACING LEAD, MODEL PY2
FDA 510(k)
FDA Class 3
·Cardiovascular
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 Biotronik, GmbH & Co.
| K Number | Device Name | ||
|---|---|---|---|
| K000763 | PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051 | Apr 6, 2000 | Substantially Equivalent - Subject to Tracking Reg. |
| K923406 | BIOSCOPE | Sep 22, 1993 | Substantially Equivalent |
| K923026 | PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER | Aug 19, 1993 | Substantially Equivalent |
| K922742 | HPM 40 HEART PACEMAKER MONITOR | Mar 18, 1993 | Substantially Equivalent |
| K914109 | PIKOS 01 & PIKOS E 01 | Feb 26, 1992 | Substantially Equivalent |
| K910609 | PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP | Aug 28, 1991 | Substantially Equivalent |
| K911142 | LEAD TERMINAL PIN CAPS, VARIOUS MODELS | Aug 9, 1991 | Substantially Equivalent |
| K905087 | TRIOS 02 | May 7, 1991 | Substantially Equivalent |
| K903928 | LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP | Oct 16, 1990 | Substantially Equivalent |
| K903929 | LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP | Oct 16, 1990 | Substantially Equivalent |