Next Generation Aspiration Catheter; Balt Aspiration Tubing Set
FDA 510(k) K234083 · Balt USA, LLC
510(k) numberK234083
Submission
- Device name
- Next Generation Aspiration Catheter; Balt Aspiration Tubing Set
- Applicant
- Balt USA, LLC
Irvine, CA, US - Received
- December 22, 2023
- Decision date
- July 2, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NRY – Catheter, Thrombus Retriever
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.
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| K260617 | Tigertriever 13 Ultra Revascularization DeviceNRY · Traditional | Rapid Medical Ltd. | 08/28/2026SE |
| K262398 | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setNRY · Special | CERENOVUS, Inc. | 08/13/2026SE |
| K262399 | Millipede SystemNRY · Special | Perfuze, Ltd. | 08/12/2026SE |
| K262391 | APRO 35 Swift Catheter and Alembic Aspiration TubingNRY · Special | Alembic, LLC | 08/12/2026SE |
| K260002 | Socrates Aspiration System (Socrates 70 Aspiration Catheter)NRY · Traditional | Scientia Vascular, Inc. | 07/16/2026SE |
| K250690 | Penumbra System (Thunderbolt Aspiration Tubing)NRY · Traditional | Penumbra, Inc. | 06/10/2026SE |
| K252707 | Zenith Aspiration Catheter; Disposable Aspiration Tubing SetNRY · Traditional | Suzhou Zenith Vascular SciTech Limited | 05/20/2026SE |
| K254276 | Lynx Aspiration Catheter SystemNRY · Traditional | QApel Medical, Inc. | 05/07/2026SE |
| K253590 | Millipede SystemNRY · Traditional | Perfuze, Ltd. | 03/16/2026SE |
| K253062 | Tigertriever 25 Revascularization DeviceNRY · Traditional | Rapid Medical Ltd. | 03/12/2026SE |
More from Rapid Medical Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260199 | SLIM MicrocatheterQJP · Traditional | 07/13/2026SE |
| K254223 | Next Generation 088 CatheterQJP · Traditional | 04/16/2026SE |
| K254221 | Optima Coil System (OptiOne Coil System)HCG · Special | 01/27/2026SE |
| K252569 | Carrier XL Delivery CatheterQJP · Special | 10/22/2025SE |
| K252700 | Optima Coil System (Optima Packing Coil System)HCG · Special | 09/26/2025SE |
| K243948 | Raptor Aspiration Catheter; Balt Aspiration Tubing SetNRY · Traditional | 06/03/2025SE |
| K251383 | Prestige Coil System (Prestige Packing Line Extension)KRD · Special | 05/30/2025SE |
| K242376 | Next Generation Access PlatformQJP · Traditional | 12/30/2024SE |
| K242582 | Optima Coil System (OptiBlock Line Extension)HCG · Special | 09/27/2024SE |
| K234074 | Next Generation Access CatheterQJP · Traditional | 07/02/2024SE |
Questions and answers
When was Next Generation Aspiration Catheter; Balt Aspiration Tubing Set cleared by the FDA?
Next Generation Aspiration Catheter; Balt Aspiration Tubing Set (K234083) received a 510(k) decision of Substantially Equivalent on July 2, 2024, 193 days after the submission was received.
What is the product code of K234083?
The FDA product code is NRY – Catheter, Thrombus Retriever, a Class II (moderate risk) device regulated under 21 CFR 870.1250.