Chrysalis Intelligence · Product Codes · QNR

QNR · Unclassified

8 clearances · 5 unique sponsors

Device class
Regulation —
Total clearances
8
2021-03-26 → 2025-05-20
Last 12 months
0
Unique sponsors
5
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Cardiacassist, Inc. 3 0 2024-01-19
Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) 2 0 2023-08-25
ABBOTT MEDICAL 1 0 2024-01-26
Medtronic, Inc. 1 0 2025-05-20
Abbott (Formerly Thoratec Corporation) 1 0 2022-12-08
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
33945 CPT High Insertion of left ventricular assist device (LVAD) for destination therapy
33946 CPT High Insertion of implantable heart assist device (ECMO); intra-operative
33949 CPT Medium Insertion of implantable heart assist device (ECMO); percutaneous peripheral approach
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-05-20 K250199 Medtronic, Inc. VitalFlow Console
2024-01-26 K234118 ABBOTT MEDICAL CentriMag™ Acute Circulatory Support System
2024-01-19 K233736 Cardiacassist, Inc. LifeSPARC System
2023-08-25 K230364 Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) VitalFlow™ Console
2023-08-25 K223898 Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) VitalFlowTM Centrifugal Pump
2022-12-08 K222038 Abbott (Formerly Thoratec Corporation) CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System
2022-11-15 K211830 Cardiacassist, Inc. LifeSPARC System
2021-03-26 K202751 Cardiacassist, Inc. TandemHeart Pump and Escort Controller