Chrysalis Intelligence · Product Codes · PPW

PPW · Adjunctive Cardiovascular Status Indicator

Cardiovascular · 6 clearances · 3 unique sponsors

Device class
Class II
Regulation 870.2200
Total clearances
6
2022-06-17 → 2026-04-03
Last 12 months
2
Unique sponsors
3
Definition

What is Adjunctive Cardiovascular Status Indicator

The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
Medical specialty
Cardiovascular
Review panel
CV
Regulation number
870.2200
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
Etiometry, Inc. 4 1 2026-04-03
Flashback Technologies, Inc. 1 0 2022-06-17
Prolaio, Inc. 1 1 2025-12-16
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
93000 CPT Medium Electrocardiogram, complete, at least 12 leads; interpretation and report only
C1770 HCPCS Imaging coil, magnetic resonance (insertable) ✓ CMS-verified description Low Cardiac device sensor, invasive, each
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-04-03 K254066 Etiometry, Inc. Etiometry Platform
2025-12-16 K252204 Prolaio, Inc. prolaio eVO2peak Module (Version 1.0)
2025-02-12 K241479 Etiometry, Inc. Etiometry Platform (DAV 5.4 RAE 9.2)
2023-07-07 K223578 Etiometry, Inc. T3 Platform software
2022-06-22 K213230 Etiometry, Inc. T3 Platform Software
2022-06-17 K213255 Flashback Technologies, Inc. CipherOx CRI Tablet