Agiltrac .035 Peripheral Dilatation Catheter
510(k) K023320
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK023320 | Date10 Dec 2002 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DQY
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1250
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Agiltrac .035 Peripheral Dilatation Catheter is a percutaneous catheter designed for peripheral vessel dilatation. It incorporates a balloon that can be inflated to diameters ranging from 4 mm to 14.5 mm in 1 mm increments, with available balloon lengths of 20, 30, 40 and 60 mm and system lengths of 80 cm and 135 cm, allowing treatment of a variety of peripheral arterial lesions.
The device is cleared under FDA 510(k) submission K023320 as a Class II catheter (product code DQY) with a traditional clearance type and a decision date of 10 December 2002. It is supplied by Guidant Corp. in Menlo Park, California, and is identified as a single‑use, sterile catheter intended for use in accordance with its labeling.
Other devices from Guidant Corp.
Questions
AI-generated answers, 23 Sep 2026
What vessel sizes can the AGILTRAC .035 catheter treat?
It can dilate peripheral vessels with balloon diameters ranging from 4 mm to 14.5 mm in 1 mm steps, allowing clinicians to match the balloon size to the specific arterial lesion for optimal expansion.
How is the catheter supplied and intended for use?
Guidant Corp. provides the catheter as a sterile, single‑use product. It is packaged ready for percutaneous insertion and must be used according to the labeling, ensuring no reuse to maintain safety and performance.
What balloon length options are available?
The device offers balloon lengths of 20 mm, 30 mm, 40 mm, and 60 mm, giving flexibility to treat lesions of varying longitudinal extent while using the same catheter platform.
What system lengths does the catheter come in?
Two system lengths are offered: an 80 cm shaft for shorter access routes and a 135 cm shaft for longer peripheral pathways, allowing selection based on patient anatomy and procedural requirements.