Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Raptor Aspiration Catheter; Balt Aspiration Tubing Set

K-Number: K243948 · 2025-06-03

ApplicantBalt USA, LLC
Decision Date2025-06-03
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Raptor Aspiration Catheter; Balt Aspiration Tubing Set is a medical device manufactured by Balt USA, LLC. It received FDA 510(k) clearance on 2025-06-03 under approval number K243948. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Raptor Aspiration Catheter; Balt Aspiration Tubing Set?

Raptor Aspiration Catheter; Balt Aspiration Tubing Set is a medical device that received FDA 510(k) clearance on 2025-06-03. It is manufactured by Balt USA, LLC. The 510(k) number is K243948.

When was Raptor Aspiration Catheter; Balt Aspiration Tubing Set approved by the FDA?

Raptor Aspiration Catheter; Balt Aspiration Tubing Set received FDA 510(k) clearance on 2025-06-03, under approval number K243948.

What company makes Raptor Aspiration Catheter; Balt Aspiration Tubing Set?

Raptor Aspiration Catheter; Balt Aspiration Tubing Set is manufactured by Balt USA, LLC.

What is the FDA product code for Raptor Aspiration Catheter; Balt Aspiration Tubing Set?

The FDA product code for Raptor Aspiration Catheter; Balt Aspiration Tubing Set is NRY.

Related Clinical Trials

NCT07216170 REVascularization In Large VEssel Occlusion for Acute Ischemic Stroke NOT_YET_RECRUITING NCT07274527 Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure RECRUITING NCT07571954 Efficacy and Safety Evaluation of iNstroke 5F Aspiration Catheter for Thrombectomy NOT_YET_RECRUITING NCT06615713 CLinical Evaluation of Aspiration for Removal ANd ClearancE of Stones COMPLETED

Other Devices by Balt USA, LLC

K182337HYBRID Guidewire K183045Eclipse 2L K182918Ballast 088 Long Sheath K200030Optima Coil System K202366MAGIC Infusion Catheter K223386Optima Coil System

View all 19 devices →

Related Devices (Code: NRY)

K161879Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K161640Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. K161064Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. K160449Penumbra System, Penumbra Pump MAXPenumbra, Inc. K152541Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. K172448Riptide Aspiration SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑