FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
ENDOCARDIAL LEADS 414S & 515S
K Number: K802816
·
Decision Jan 16, 1981
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
486
Applicant Total
63
Review Days
70
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Basic Information
- Device Name
- ENDOCARDIAL LEADS 414S & 515S
- K Number
- K802816
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Siemens Elema AB
- Date Received
- November 7, 1980
- Decision Date
- January 16, 1981
- 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.
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MODEL 5071 MYOCARDIAL PACING LEAD
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MODEL 4951M MYOCARDIAL UNIPOLAR LEAD
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ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP
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|---|---|---|---|
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| K010925 | SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E | Dec 18, 2001 | Substantially Equivalent |
| K002137 | CATHCOR DESKTOP | Oct 5, 2000 | Substantially Equivalent |
| K001315 | MODIFICATION TO KION ANESTHESIA SYSTEM | May 26, 2000 | Substantially Equivalent |
| K970839 | SERVO VENTILATOR 300A | Oct 14, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K960010 | SERVO VENTILATOR 300 COMPUTER INTERFACE | Oct 25, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K960168 | SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990 | Oct 25, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K872278 | SIEMENS O2-AIR MIXER 965 | Sep 3, 1987 | Substantially Equivalent |
| K871354 | SERVO VENTILATOR 900 C/D | Jul 21, 1987 | Substantially Equivalent |