FDA 510(k)
FDA class 3
Substantially Equivalent - Subject to Tracking Reg.
🇺🇸 United States
YP 45/15-BP; YP 53/15-BP; YP 60/15-BP
K Number: K993139
·
Decision Dec 17, 1999
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
486
Applicant Total
85
Review Days
88
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Basic Information
- Device Name
- YP 45/15-BP; YP 53/15-BP; YP 60/15-BP
- K Number
- K993139
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Applicant
- Biotronik, Inc.
- Date Received
- September 20, 1999
- Decision Date
- December 17, 1999
- 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 4951M MYOCARDIAL UNIPOLAR LEAD
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ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP
FDA 510(k)
FDA Class 3
·Cardiovascular
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|---|---|---|---|
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| K242969 | Pantera Pro; Pantera LEO | Oct 25, 2024 | Substantially Equivalent |
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| K241711 | Oscar Peripheral Multifunctional Catheter system | Jul 11, 2024 | Substantially Equivalent |
| K230375 | BIOMONITOR IV | May 19, 2023 | Substantially Equivalent |
| K222065 | Passeo-35 Xeo Peripheral Dilatation Catheter | Feb 16, 2023 | Substantially Equivalent |
| K221856 | BIOMONITOR IIIm, BIOMONITOR III | Jul 27, 2022 | Substantially Equivalent |
| K222037 | Selectra Lead Implantation System | Jul 19, 2022 | Substantially Equivalent |
| K214038 | Oscar Peripheral Multifunctional Catheter system | Jul 6, 2022 | Substantially Equivalent |