Device Listing 1196614779

Listing Summary#

Listing key
1196614779
Premarket submission
K230309
Device
Intra-Operative Positioning System (IOPSĀ®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1)
Applicant
Centerline Biomedical, Inc.
Product code
DQK
Decision date
2023-06-21