FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
ENDOCARD. PACIN/ LEAD-STD. LENGTH PL100
K Number: K771564
·
Decision Sep 14, 1977
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
486
Applicant Total
63
Review Days
37
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Basic Information
- Device Name
- ENDOCARD. PACIN/ LEAD-STD. LENGTH PL100
- K Number
- K771564
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Daig Corp.
- Date Received
- August 8, 1977
- Decision Date
- September 14, 1977
- 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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| K965249 | SPYGLASS ANGIOGRAPHIC CATHETER | Feb 21, 1997 | Substantially Equivalent |
| K962805 | SPYGLASS ANGIOGRAPHIC CATHETER | Oct 15, 1996 | Substantially Equivalent |
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