FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PA
K Number: K844752
·
Decision Jan 2, 1985
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
486
Applicant Total
8
Review Days
27
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
- TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PA
- K Number
- K844752
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Mansfield Scientific, Inc.
- Date Received
- December 6, 1984
- Decision Date
- January 2, 1985
- 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 Mansfield Scientific, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K865017 | ANGIOSCOPE | Dec 15, 1987 | Substantially Equivalent |
| K870186 | ENDOMYOCARDIAL BIOPSY DEVICE | Feb 20, 1987 | Substantially Equivalent |
| K855103 | CIRIBART GYUDUBG CATGETER | Feb 18, 1986 | Substantially Equivalent |
| K853850 | EXPLORER | Dec 4, 1985 | Substantially Equivalent |
| K852797 | HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE | Sep 16, 1985 | Substantially Equivalent |
| K851848 | PERCUTANEOUS TRANSLUMINAL BLOOD DILATION CATHETER | Jul 19, 1985 | Substantially Equivalent |
| K841705 | WEDGE PRESSURE CATHETER FLOW DIRECTED | Jul 13, 1984 | Substantially Equivalent |