LDF · Electrode, Pacemaker, Temporary · Chrysalis Intelligence

Device class

Class II

Regulation 870.3680

Total clearances

2024-04-26 → 2026-07-30

Last 12 months

Unique sponsors

Classification details

Medical specialty

Cardiovascular

Review panel

Regulation number

870.3680

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
C.R. Bard, Inc.	2	0	2025-05-15
Shenzhen Launch Electrical Co., Ltd.	1	0	2025-01-23
Osypka AG	1	0	2024-04-26
Swift Sync, Inc.	1	1	2026-07-30
Bioptimal International Pte. , Ltd.	1	0	2025-06-15
Medtronic, Inc.	1	0	2025-01-17

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.

Code	Type	Description	Confidence	Rationale
93000	CPT	—	Medium	Pacemaker electrode insertion/placement, though temporary electrode may vary
C1895	HCPCS	Lead, cardioverter-defibrillator, endocardial dual coil (implantable) ✓ CMS-verified description	Medium	Pacemaker lead, temporary transvenous

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-30	K252042	Swift Sync, Inc.	Sync AV II Temporary Pacing Catheter
2025-06-15	K242863	Bioptimal International Pte. , Ltd.	Bioptimal Bipolar Pacing Catheter
2025-05-15	K251186	C.R. Bard, Inc.	Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
2025-01-31	K241334	C.R. Bard, Inc.	Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH Temporary Pacing Electrode Catheter,
2025-01-23	K241199	Shenzhen Launch Electrical Co., Ltd.	Rotatable Connector (5944RL)
2025-01-17	K242705	Medtronic, Inc.	Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)
2024-04-26	K232261	Osypka AG	TME Temporary Myocardial Electrode