FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE
K Number: K852797
·
Decision Sep 16, 1985
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
128
Applicant Total
8
Review Days
80
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
- HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE
- K Number
- K852797
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Mansfield Scientific, Inc.
- Date Received
- June 28, 1985
- Decision Date
- September 16, 1985
- Product Code
- LDF
- 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 |
|---|---|---|---|
| LDF | Electrode, Pacemaker, Temporary | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LDF), ordered by most recent decision date.
Bioptimal Bipolar Pacing Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
FDA 510(k)
FDA Class 2
·Cardiovascular
Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH Temporary Pacing Electrode Catheter,
FDA 510(k)
FDA Class 2
·Cardiovascular
Rotatable Connector (5944RL)
FDA 510(k)
FDA Class 2
·Cardiovascular
Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)
FDA 510(k)
FDA Class 2
·Cardiovascular
TME Temporary Myocardial Electrode
FDA 510(k)
FDA Class 2
·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 |
| K851848 | PERCUTANEOUS TRANSLUMINAL BLOOD DILATION CATHETER | Jul 19, 1985 | Substantially Equivalent |
| K844752 | TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PA | Jan 2, 1985 | Substantially Equivalent |
| K841705 | WEDGE PRESSURE CATHETER FLOW DIRECTED | Jul 13, 1984 | Substantially Equivalent |