Chrysalis Intelligence · Product Codes · PSQ

PSQ · Intracardiac Patch Or Pledget, Biologically Derived

Cardiovascular · 5 clearances · 4 unique sponsors

Device class
Class II
Regulation 870.3470
Total clearances
5
2020-02-13 → 2022-10-19
Last 12 months
0
Unique sponsors
4
Definition

What is Intracardiac Patch Or Pledget, Biologically Derived

To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature.
Medical specialty
Cardiovascular
Review panel
CV
Regulation number
870.3470
Implant
Y
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Synovis Life Technologies, Inc. 2 0 2022-10-19
Helios Cardio, Inc. 1 0 2021-12-21
Lemaitre Vascular 1 0 2020-02-13
Admedus Regen Pty, Ltd. 1 0 2020-04-03
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
0347T CPT Medium Cardiac tissue patch graft application code for congenital repairs
33505 CPT Medium Repair of cardiac septal defect with biologic graft material
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2022-10-19 K221032 Synovis Life Technologies, Inc. Vascu-Guard Vascular Repair Patch
2022-10-19 K221029 Synovis Life Technologies, Inc. PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch
2021-12-21 K210331 Helios Cardio, Inc. CardiaMend Pericardial and Epicardial Reconstruction Matrix
2020-04-03 K200566 Admedus Regen Pty, Ltd. ADAPT Tissue
2020-02-13 K190882 Lemaitre Vascular XenoSure Biologic Patch