Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters) +1 more— 510(k) K241243
Substantially EquivalentCenterline Biomedical, Inc.
FDA 510(k) clearance K241243 for Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters) +1 more, Substantially Equivalent on 2024-07-24. Applicant: Centerline Biomedical, Inc.. Device class: 2.
Clearance details
- Device name as filed
- Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters)
- Applicant
- Centerline Biomedical, Inc.
- Product code
- Code DQK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1425
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Cleveland, OH, US
Recent devices under product code DQK
view allMore clearances from Centerline Biomedical, Inc.
view all- K254089 — IOPS Visionary System (MC-3) +7 more
- K243842 — Intra-Operative Positioning System (IOPS®)
- K242133 — Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad) +1 more
- K230309 — Intra-Operative Positioning System (IOPS®) (MC-1) +4 more
- K190106 — Intra-Operative Positioning System +4 more
Adverse events under product code DQK
product code DQK- Death
- 10
- Injury
- 225
- Malfunction
- 2,123
- Other
- 2
- Total
- 2,360
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K241243
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K241243.
Data sourced from openFDA. This site is unofficial and independent of the FDA.