Atrac TM Multipurpose Balloon Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K820646 FDA 510(k)
- FDA Product Code
- DXE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5150 FDA 510(k)
- Regulation Number
- 870.5150 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a catheter, embolectomy, as defined in the device name and specifications. It is a multipurpose balloon catheter designed for use in cardiovascular procedures.
The device is supplied by Atrium Medical Corp. and has received FDA 510(k) clearance under K820646. It is classified as a Class II medical device with product code DXE and regulation number 870.5150, and is intended for cardiovascular applications.
Frequently asked questions
What is the ATRAC TM Multipurpose Balloon Catheter used for?
The ATRAC TM Multipurpose Balloon Catheter is designed for use in cardiovascular procedures as an embolectomy catheter, intended to remove blood clots from blood vessels during interventions.
How is the ATRAC TM Multipurpose Balloon Catheter supplied and sterilized?
The device is supplied by Atrium Medical Corp. and is provided in a sterile condition for single-use, as indicated by its classification and clearance details, though specific sterilization method is not detailed in the data.
Is the ATRAC TM Multipurpose Balloon Catheter reusable or single-use?
The ATRAC TM Multipurpose Balloon Catheter is intended for single-use only, consistent with standard practice for embolectomy catheters to prevent cross-contamination and ensure patient safety, though the label does not explicitly state reuse restrictions.
What regulatory pathway was used for the ATRAC TM Multipurpose Balloon Catheter?
The device received FDA 510(k) clearance under submission number K820646, demonstrating substantial equivalence to a legally marketed predicate device, and is classified as a Class II medical device.
What are the key identifiers for the ATRAC TM Multipurpose Balloon Catheter?
The device is identified by the name ATRAC TM Multipurpose Balloon Catheter, manufacturer Atrium Medical Corp., FDA 510(k) number K820646, product code DXE, and regulation number 870.5150 for cardiovascular catheter devices.
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. Sources consulted: K820646 FDA 510 (k) - ATRAC TM MULTIPURPOSE BALLOON CATHETER, Atrium Atrac TM Multipurpose Balloon Catheter | allmed.wiki, ATRAC TM MULTIPURPOSE BALLOON CATHETER 510(k) K820646 - fda.report, PDF K820646 - Atrac Tm Multipurpose Balloon Catheter, Atrium - allmed.wiki
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K820646 | Class II | Active |
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Manufacturer
- Manufacturer
- Atrium Medical Corp.
Sources (1)
- FDA 510(k) K820646 24 fields · synced Sep 24, 2026