Chrysalis Intelligence · Product Codes · DTE

DTE · Unclassified

3 clearances · 3 unique sponsors

Device class
Regulation —
Total clearances
3
2020-05-13 → 2025-01-10
Last 12 months
0
Unique sponsors
3
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
Solo Pace, Inc. 1 0 2025-01-10
Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. 1 0 2024-01-07
Medtronic, Inc. 1 0 2020-05-13
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 Cardiac monitoring with external pacemaker pulse generator
93042 CPT Medium Rhythm strip interpretation with external pacing
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-01-10 K241781 Solo Pace, Inc. Solo Pace Control
2024-01-07 K232721 Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. Lifetech Cardio Temporary Pacemaker
2020-05-13 K201011 Medtronic, Inc. Medtronic Model 5392 External Pulse Generator (EPG)