510(k) Report

Devices descending from K183043

7 later devices reach 0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202182ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingImperative Care, Inc.20206Class I
+2K210996ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingImperative Care, Inc.20215Class I
+3K243948Raptor Aspiration Catheter; Balt Aspiration Tubing SetBalt USA, LLC20250—
+3K242672Zoom SystemImperative Care, Inc.20250—
+3K211476ZOOM 71 Reperfusion Catheter; ZOOM Aspiration TubingImperative Care, Inc.20213—
+4K243047Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration TubingImperative Care, Inc.20250—
+4K234083Next Generation Aspiration Catheter; Balt Aspiration Tubing SetBalt USA, LLC20240—