ATB Advance PTA Dilatation Catheter
FDA 510(k)Class II (US FDA 510(k))
by Cook, Inc.
Identifiers
- 510(k) Number
- K113300 FDA 510(k)
- FDA Product Code
- LIT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ATB Advance PTA Dilatation Catheter is a peripheral transluminal angioplasty catheter designed for use in cardiovascular procedures. It is classified as a Class II medical device and is substantially equivalent to a legally marketed predicate device.
This device is supplied sterile and intended for single-use. It is used in clinical settings for percutaneous transluminal angioplasty of peripheral arteries, as indicated by its FDA 510(k) clearance under product code LIT and regulation number 870.1250.
Frequently asked questions
What is the ATB Advance PTA Dilatation Catheter used for?
It is used in clinical settings for percutaneous transluminal angioplasty of peripheral arteries, as indicated by its FDA 510(k) clearance under product code LIT and regulation number 870.1250.
Is the ATB Advance PTA Dilatation Catheter sterile and single-use?
Yes, the device is supplied sterile and intended for single-use only, as stated in the device description, to ensure patient safety and prevent cross-contamination during peripheral angioplasty procedures.
What regulatory pathway was used for the ATB Advance PTA Dilatation Catheter?
The device received FDA 510(k) clearance, demonstrating substantial equivalence to a legally marketed predicate device, with clearance type classified as 'Special' under product code LIT.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K113300 | Class II | Active |
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Manufacturer
- Manufacturer
- Cook, Inc.
Sources (1)
- FDA 510(k) K113300 24 fields · synced Sep 21, 2026