VersaCross Connect Transseptal Dilator— 510(k) K233647

Name: FDA 510(k) clearance K233647
Creator: U.S. Food and Drug Administration
Published: 2023-12-14

Substantially Equivalent

Baylis Medical Company, Inc.

FDA 510(k) clearance K233647 for VersaCross Connect Transseptal Dilator, Substantially Equivalent on 2023-12-14. Applicant: Baylis Medical Company, Inc.. Device class: 2.

Clearance details

Applicant: Baylis Medical Company, Inc.
Product code: Code DRE
Device class: Class 2
Regulation: 21 CFR 870.1310
Advisory panel: Cardiovascular
Date received: 2023-11-14
Decision date: 2023-12-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Mississauga, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRE

view all

K261310 — FlexTract Deflectable-Rotational Dilator Sheath Set2026-07-27
K253616 — ProtekDilate Vascular Access Kit2025-12-19
K251325 — VersaCross Connect Transseptal Dilator2025-05-29
K242229 — Micro Ace Gold Advanced Micro Access System2025-01-15
K241720 — VersaCross Connect Transseptal Dilator2024-07-12

More clearances from Baylis Medical Company, Inc.

view all

K231227 — SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath2023-12-20
K213898 — ProTrack Pigtail Wire2023-03-01
K221351 — Mechanical Guidewire2022-12-19
K213582 — Epicardial Access System2022-06-30
K220414 — VersaCross Connect Transseptal Dilator2022-05-09

Adverse events under product code DRE

product code DRE

Death: 100
Injury: 832
Malfunction: 597
Other: 3
Total: 1,532

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 →

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