FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TEMP. CARDIAC PACING WIRE TME 60/61/65
K Number: K831695
·
Decision Oct 20, 1983
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
128
Applicant Total
49
Review Days
148
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
- TEMP. CARDIAC PACING WIRE TME 60/61/65
- K Number
- K831695
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Oscor, Inc.
- Date Received
- May 25, 1983
- Decision Date
- October 20, 1983
- 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 Oscor, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K210627 | Breezeway II | Jun 3, 2021 | Substantially Equivalent |
| K151951 | Destino Reach | Sep 22, 2015 | Substantially Equivalent |
| K143463 | IS4/DF4 Port Plug | Mar 19, 2015 | Substantially Equivalent |
| K140917 | INTRODUCER, MODEL ADELANTE MAGNUM | Jul 9, 2014 | Substantially Equivalent |
| K140406 | DESTINO TWIST, STEERABLE GUIDING SHEATH | Apr 17, 2014 | Substantially Equivalent |
| K130633 | INTRODUCER SETS, MODEL ADELANTE RADIAL | Feb 13, 2014 | Substantially Equivalent |
| K130843 | SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE | Jan 8, 2014 | Substantially Equivalent |
| K130104 | GUIDEWIRE, PURSUER SERIES | Jun 13, 2013 | Substantially Equivalent |
| K122960 | STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO | Dec 13, 2012 | Substantially Equivalent |
| K122958 | DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY | Dec 13, 2012 | Substantially Equivalent |