SelectSite C304-HIS Deflectable Catheter System— 510(k) K183493

Name: FDA 510(k) clearance K183493
Creator: U.S. Food and Drug Administration
Published: 2019-03-15

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K183493 for SelectSite C304-HIS Deflectable Catheter System, Substantially Equivalent on 2019-03-15. Applicant: Medtronic, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic, Inc.
Product code: Code DQY
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2018-12-17
Decision date: 2019-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

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K262240 — SSPC NXT Delivery Catheter2026-07-29
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Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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 K183493

K-number listed on FDA's recall record

Z-1206-2022 — The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a catheter dilator to facilitate deflectable catheter passage, and a guide catheter slitter to remove the deflectable catheter. The deflectable catheter is designed for placement of transvenous devices in or near the bundle of His. It features a deflecting distal section, controlled by the deflectable catheter handle, and an out-of plane curve on the distal tip. The body of the deflectable catheter is radiopaque for visibility on fluoroscopy.Class II·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·20220420

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183493.

Data sourced from openFDA. This site is unofficial and independent of the FDA.