(64 days)
Not Found
Not Found
No
The device description focuses on the physical components and mechanical function of a balloon dilatation catheter, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is recommended for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions in arteries and dialysis fistulae, which is a therapeutic intervention aimed at restoring blood flow and improving patient health.
No
The device description clearly states it is a "Balloon Dilatation Catheter" used for angioplasty, which is a therapeutic procedure to open vessels. While it can monitor pressure, its primary function is not to diagnose a condition but to treat it.
No
The device description clearly details a physical catheter with a balloon, lumens, and radiopaque markers, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The description clearly states that this device is a "Peripheral Balloon Dilatation Catheter" used for "Percutaneous Transluminal Angioplasty (PTA)". This is a procedure performed within the body to widen narrowed or blocked blood vessels.
- Lack of Sample Analysis: There is no mention of this device being used to analyze samples taken from the body. Its function is mechanical intervention within the vascular system.
Therefore, the Bard Tru-Trac Peripheral Balloon Dilatation Catheter is a therapeutic medical device used for a surgical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
"Recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Any use of this product for procedures other than those indicated is not recommended."
Product codes
Not Found
Device Description
The Bard Tru-Trac Peripheral Balloon Dilatation Catheter is a multilumen catheter with a discrete balloon mounted on its distal tip. The clear lumen, labeled "balloon", is for balloon inflation. The green lumen, labeled "distal", allows the catheter to track over a guidewire and can be used for monitoring of pressure or infusion of medication and/or contrast medium.
The catheter shaft gradually tapers beneath the balloon, nominally one french size. The tip is further tapered to provide a smooth interface with a Bard .035" PTFE-coated guidewire. Two radiopaque markers are placed beneath the "working area" of the balloon.
The balloon is wrapped clockwise (when viewed from the proximal shaft to the distal tip) around the shaft and is protected by a balloon folding tool prior to sterilization. A stylette is inserted in the distal (guidewire) lumen beneath the balloon folding tool.
The Bard Tru-Trac Peripheral Balloon Dilatation Catheter is available in various models incorporating balloon diameters (inflated) of 4mm-10mm; balloon lengths of 2, 3, 4, 8 and 10 cm; shaft lengths ranging from 45 to 125cm (standard lengths of 45, 75, 85 and 125cm); and shaft diameter of 5 Fr. (for balloons with inflated diameters
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Bard Radiology Division 13183 Harland Dr., N.E. Covington, GA 30209
K960517
SECTION VI
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
A. Submitter Information:
Submitter's Name: C. R. Bard, Inc., Radiology Division Submitter's Address: 13183 Harland Drive, Covington, GA 30209 Contact Person: Donna J. Wilson Contact Person's Address: 8195 Industrial Blvd., Covington, GA 30209 Contact Person's Telephone Number: 770-784-6135 Contact Person's FAX Number 770-784-6419 Date of Preparation: February 2, 1996
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B. Device Name:
Bard® Tru-Trac™ Peripheral Balloon Dilatation Catheter -
C. Predicate Device Name:
Medi-Tech® Ultra-Thin™ Balloon Dilatation Catheter -
D. Device Description
The Bard Tru-Trac Peripheral Balloon Dilatation Catheter is a multilumen catheter with a discrete balloon mounted on its distal tip. The clear lumen, labeled "balloon", is for balloon inflation. The green lumen, labeled "distal", allows the catheter to track over a guidewire and can be used for monitoring of pressure or infusion of medication and/or contrast medium.
The catheter shaft gradually tapers beneath the balloon, nominally one french size. The tip is further tapered to provide a smooth interface with a Bard .035" PTFE-coated guidewire. Two radiopaque markers are placed beneath the "working area" of the balloon.
480-06
1
The balloon is wrapped clockwise (when viewed from the proximal shaft to the distal tip) around the shaft and is protected by a balloon folding tool prior to sterilization. A stylette is inserted in the distal (guidewire) lumen beneath the balloon folding tool.
The Bard Tru-Trac Peripheral Balloon Dilatation Catheter is available in various models incorporating balloon diameters (inflated) of 4mm-10mm; balloon lengths of 2, 3, 4, 8 and 10 cm; shaft lengths ranging from 45 to 125cm (standard lengths of 45, 75, 85 and 125cm); and shaft diameter of 5 Fr. (for balloons with inflated diameters