FDA 510(k)
FDA class 3
Unknown
🇺🇸 United States
PASSIVE PLUS ENDOCARDIAL PACING LEADS VAR. MODELS
K Number: K932892
·
Decision Jul 6, 1994
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
486
Applicant Total
7
Review Days
387
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Basic Information
- Device Name
- PASSIVE PLUS ENDOCARDIAL PACING LEADS VAR. MODELS
- K Number
- K932892
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Siemens-Pacesetter, Inc.
- Date Received
- June 14, 1993
- Decision Date
- July 6, 1994
- 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
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MODEL 5071 MYOCARDIAL PACING LEAD
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MODEL 4951M MYOCARDIAL UNIPOLAR LEAD
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FDA Class 3
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ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP
FDA 510(k)
FDA Class 3
·Cardiovascular
Other Clearances by Siemens-Pacesetter, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942440 | AFP CARDIAC PACING SYSTEM MODEL 283 | Aug 8, 1994 | Substantially Equivalent - Subject to Tracking Reg. |
| K925038 | PACING LEAD MODEL 1188T | Jul 15, 1994 | Substantially Equivalent - Subject to Tracking Reg. |
| K930876 | SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T | Jun 15, 1994 | Substantially Equivalent - Subject to Tracking Reg. |
| K925347 | MODEL 1148T TRANSVENOUS, SCREW-IN LEAD | Jun 10, 1993 | Substantially Equivalent |
| K920822 | CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE | Jan 22, 1993 | Unknown |
| K921318 | ADAPTING SLEEVE KIT MODEL 4023 | Aug 3, 1992 | Substantially Equivalent |