FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
STOCKERT CARDIAC PACING ELECTRODES
K Number: K812049
·
Decision Mar 18, 1982
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
486
Applicant Total
13
Review Days
240
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- STOCKERT CARDIAC PACING ELECTRODES
- K Number
- K812049
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Stoeckert Instrumente
- Date Received
- July 21, 1981
- Decision Date
- March 18, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DTB), ordered by most recent decision date.
BIOTRONIK ENDOCARDIAL PACING LEADS
FDA 510(k)
FDA Class 3
·Cardiovascular
PERMANENT PACING LEAD, MODEL PY2
FDA 510(k)
FDA Class 3
·Cardiovascular
PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU
FDA 510(k)
FDA Class 3
·Cardiovascular
MODEL 5071 MYOCARDIAL PACING LEAD
FDA 510(k)
FDA Class 3
·Cardiovascular
MODEL 4951M MYOCARDIAL UNIPOLAR LEAD
FDA 510(k)
FDA Class 3
·Cardiovascular
ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP
FDA 510(k)
FDA Class 3
·Cardiovascular
Other Clearances by Stoeckert Instrumente
| K Number | Device Name | ||
|---|---|---|---|
| K002273 | STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE | Jan 29, 2001 | Substantially Equivalent |
| K001961 | STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE | Jan 25, 2001 | Substantially Equivalent |
| K002118 | STOCKERT COMPACT SYSTEM VERSION 2.0 | Aug 9, 2000 | Substantially Equivalent |
| K992635 | INTERFACE MODULE IDDD | Dec 20, 1999 | Substantially Equivalent |
| K990512 | STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS | Nov 23, 1999 | Substantially Equivalent |
| K982014 | STOCKERT COMPACT SYSTEM | Sep 4, 1998 | Substantially Equivalent |
| K972321 | S3 MAST PUMP | Feb 27, 1998 | Substantially Equivalent |
| K971520 | S3 CYCLIC RPM CONTROL | Sep 10, 1997 | Substantially Equivalent |
| K962320 | S3 CARDIOPLEGIA CONTROL | Jan 10, 1997 | Substantially Equivalent |
| K955152 | STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER | Feb 22, 1996 | Substantially Equivalent |