Chrysalis Intelligence · Product Codes · DSP

DSP · System, Balloon, Intra-Aortic And Control

Cardiovascular · 4 clearances · 1 unique sponsors

Device class
Class II
Regulation 870.3535
Total clearances
4
2020-04-09 → 2025-03-26
Last 12 months
0
Unique sponsors
1
Medical specialty
Cardiovascular
Review panel
CV
Regulation number
870.3535
Implant
N
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
Arrow International, Inc. 4 0 2025-03-26
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
33973 CPT — High Standard CPT for intra-aortic balloon pump (IABP) insertion and management
33974 CPT — High Standard CPT for IABP removal
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-03-26 K250542 Arrow International, LLC AC3™ Range™ Intra-Aortic Balloon Pump
2023-08-30 K232343 Arrow International, LLC AC3™ Series IABP
2020-05-27 K201112 Arrow International, Inc. AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP
2020-04-09 K200634 Arrow International, Inc. Arrow FiberOptix Intra-Aortic Balloon Catheter Kit