FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
PERMANENT & TEMPORARY PACEMAKER ELECTR.
K Number: K820262
·
Decision Mar 12, 1982
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
486
Applicant Total
9
Review Days
38
Basic Information
- Device Name
- PERMANENT & TEMPORARY PACEMAKER ELECTR.
- K Number
- K820262
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- DIAG CORP.
- Date Received
- February 2, 1982
- Decision Date
- March 12, 1982
- 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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Other Clearances by DIAG CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K984062 | SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229 | Mar 24, 1999 | Substantially Equivalent |
| K911883 | DAIG FAST CATH(TM) TRANSSEPTAL SHEATH INTRODUCER | Nov 29, 1991 | Substantially Equivalent |
| K910645 | DISPOSABLE PATIENT CABLE | May 7, 1991 | Substantially Equivalent |
| K852446 | ENDOCARDIAL SCREW-IN LEAD WITH PLATINUM POROUS TIP | Sep 17, 1985 | Substantially Equivalent |
| K820003 | CARDIOVASCULAR TEMP. PACEMAKER ELEC | Mar 26, 1982 | Substantially Equivalent |
| K812905 | PERMANENT ENDOCARD. UNIPOLAR TINED LEAD | Feb 4, 1982 | Substantially Equivalent |
| K812270 | PERM. ENDOCARDIAL UNIPOLAR TINED ATRIAL | Sep 16, 1981 | Substantially Equivalent |
| K800349 | ENDOCARD. PACING LEAD LONG LENGTH PL200 | May 28, 1980 | Substantially Equivalent |