FDA 510(k)
FDA class 3
Substantially Equivalent - Subject to Tracking Reg.
🇺🇸 United States
EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133
K Number: K994240
·
Decision Apr 13, 2000
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
486
Applicant Total
85
Review Days
119
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Basic Information
- Device Name
- EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133
- K Number
- K994240
- 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
- December 16, 1999
- Decision Date
- April 13, 2000
- 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 |
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ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP
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| K222065 | Passeo-35 Xeo Peripheral Dilatation Catheter | Feb 16, 2023 | Substantially Equivalent |
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| K214038 | Oscar Peripheral Multifunctional Catheter system | Jul 6, 2022 | Substantially Equivalent |