Bantam Catheter (280mm Balloon Lengths)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- BANTAM EUDAMED
- Device Name
- Bantam™ PTA Balloon Catheter with SiLX2™ coating EUDAMED
- Model / Reference
- 48528050 EUDAMED48528020 EUDAMED48506020 EUDAMED48804025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391509831864 EUDAMED05391509831819 EUDAMED05391509838214 EUDAMED05391515543270 EUDAMED
- Basic UDI-DI
- 539150983JKFMQBLB6Y EUDAMED
- 510(k) Number
- K112335 FDA 510(k)
- FDA Product Code
- DQY FDA 510(k)
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Bantam OTW PTA Catheter (280mm Balloon Lengths) is an Over-The-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) catheter designed for vascular interventions. It incorporates a 280mm balloon length to facilitate dilation of peripheral arteries, aiding in the treatment of arterial stenosis or occlusions in lower limb or peripheral vascular disease settings.
This catheter is supplied as a single-use, non-sterile device and is intended for use in controlled clinical environments such as catheterization labs or angiography suites. It is regulated under FDA 510(k) clearance and EU MDR compliance, with a product code of DQY. The device is intended for over-the-wire use and requires proper sterilization prior to use, adhering to standard medical device handling protocols.
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: BANTAM CATHETER (280MM BALLOON LENGTHS) (K112335) — FDA 510 (k ..., PDF 510(K) SUMMARY - Food and Drug Administration, Bantam Catheter 280mm Balloon - Clearstream | FDA Reference
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K112335 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ClearStream Technologies , Ltd.
Sources (5)
- FDA 510(k) K112335 24 fields · synced Sep 18, 2026
- EUDAMED 8f1c30ea-6a39-4ee7-8aba-cff5508cd90b 61 fields · synced Jul 8, 2026
- EUDAMED 5fcd7dd6-2c42-4f54-ac05-403e6939e405 61 fields · synced Jul 8, 2026
- EUDAMED a6a98861-4581-4835-9ec6-f971a9c2a1ea 61 fields · synced Jul 8, 2026
- EUDAMED f5b9301f-0f09-47c1-aa14-f7ee35f02e81 61 fields · synced Aug 1, 2026