510(k) Report

Devices descending from K210996

5 later devices reach ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243948Raptor Aspiration Catheter; Balt Aspiration Tubing SetBalt USA, LLC20250—
+1K242672Zoom SystemImperative Care, Inc.20250—
+1K211476ZOOM 71 Reperfusion Catheter; ZOOM Aspiration TubingImperative Care, Inc.20213—
+2K243047Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration TubingImperative Care, Inc.20250—
+2K234083Next Generation Aspiration Catheter; Balt Aspiration Tubing SetBalt USA, LLC20240—