FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
PACEMAKER, ELECTRODE, PERMANENT & TEMP.
K Number: K780246
·
Decision Aug 31, 1978
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
486
Applicant Total
63
Review Days
199
Basic Information
- Device Name
- PACEMAKER, ELECTRODE, PERMANENT & TEMP.
- K Number
- K780246
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- DAIG CORP.
- Date Received
- February 13, 1978
- Decision Date
- August 31, 1978
- 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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| K964518 | FAST-CATH TRANSSEPTAL CATHETER INTRODUCER | May 14, 1997 | Substantially Equivalent |
| K965249 | SPYGLASS ANGIOGRAPHIC CATHETER | Feb 21, 1997 | Substantially Equivalent |
| K962805 | SPYGLASS ANGIOGRAPHIC CATHETER | Oct 15, 1996 | Substantially Equivalent |
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| K944284 | CONTROL | Mar 3, 1995 | Substantially Equivalent |