FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BARD TRU-TRAC PERIPHERAL BALLOON DILATATION CATHETER
K Number: K960517
·
Decision Apr 9, 1996
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
402
Applicant Total
645
Review Days
64
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
- BARD TRU-TRAC PERIPHERAL BALLOON DILATATION CATHETER
- K Number
- K960517
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- C.R. Bard, Inc.
- Date Received
- February 5, 1996
- Decision Date
- April 9, 1996
- Product Code
- LIT
- 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 |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LIT), ordered by most recent decision date.
WAVE PTA Balloon Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Armada 14 NC PTA Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Amethyst HP PTA OTW 0.035 Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Amethyst HP PTA OTW 0.035 Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by C.R. Bard, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit | May 29, 2026 | Unknown |
| K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) | Mar 17, 2026 | Substantially Equivalent |
| K251864 | Rubber Utility Catheter | Feb 23, 2026 | Substantially Equivalent |
| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) | May 15, 2025 | Substantially Equivalent |
| K241334 | 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, | Jan 31, 2025 | Substantially Equivalent |
| K230356 | Aspirex Thrombectomy System | Mar 31, 2023 | Substantially Equivalent |
| K223177 | Highlander 014 PTA Balloon Dilatation Catheter | Jan 20, 2023 | Substantially Equivalent |
| K222793 | WavelinQ Generator | Oct 17, 2022 | Substantially Equivalent |
| K220270 | Aspirex Thrombectomy System | Jun 21, 2022 | Substantially Equivalent |
| K213203 | Provena(TM) Midline Catheter | May 13, 2022 | Substantially Equivalent |