PTS-X Sizing Balloon Catheter
FDA 510(k)Class II (US FDA 510(k))
by NuMED, Inc.
Identifiers
- 510(k) Number
- K110903 FDA 510(k)
- FDA Product Code
- MJN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4450 FDA 510(k)
- Regulation Number
- 870.4450 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The PTS-X Sizing Balloon Catheter is an intravascular occluding catheter designed for use in patients with cardiovascular defects. It allows for the accurate measurement of a defect to assist in the selection of an appropriately sized occluder device.
This device features an inner braided catheter tubing to provide increased lumen strength, pushability, and kink-resistance. It is available in a range of diameters from 20mm to 40mm and has received FDA 510k authorization.
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: PTS®/PTS-X™ - NuMED For Children, PTS-X™ Sizing Balloon Catheters - bisusa.com, PTS® Sizing Balloon Catheters - bisusa.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K110903 | Class II | Active |
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Manufacturer
- Manufacturer
- NuMED, Inc.
Sources (1)
- FDA 510(k) K110903 24 fields · synced Sep 24, 2026