510(k) Report

Devices descending from K063091

17 later devices reach Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+1K131007Aigis RX N Medium; Aigis RX N LargeTyrx, Inc.20136—
+1K130943Aigis RX R PM/ Aigis RX R IcdTyrx, Inc.201314—
+2K180030TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope…Medtronic, Inc.20183—
+2K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+2K142611TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc.20144—
+2K132699Aigis RX N (Medium), Aigis RX N (Large)Tyrx, Inc.20135—
+3K192389TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope…Medtronic, Inc.20202—
+3K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+3K152678TYRX Neuro Antibacterial EnvelopeTyrx, Inc.20150—
+3K150291TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc.20153—
+4K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc.20241—
+4K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+4K180122TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable…Medtronic, Inc.20181—
+5K262406EluPro Antibiotic-Eluting BioEnvelopeBoston Scientific20260—
+5K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—
+5K192636TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable…Medtronic, Inc.20200—