DeviceClearance

VersaCross Transseptal Sheath— 510(k) K183655

Substantially Equivalent

Baylis Medical Company, Inc.

FDA 510(k) clearance K183655 for VersaCross Transseptal Sheath, Substantially Equivalent on 2019-05-20. Applicant: Baylis Medical Company, Inc.. Device class: 2.

Clearance details

Applicant
Baylis Medical Company, Inc.
Product code
Code DYB
Device class
Class 2
Regulation
21 CFR 870.1340
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mississauga, CA
Download summary PDFView on FDA.gov ↗

Recent devices under product code DYB

view all

More clearances from Baylis Medical Company, Inc.

view all

Adverse events under product code DYB

product code DYB
Death
808
Injury
5,922
Malfunction
16,516
Other
5
Total
23,251

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 K183655

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183655.

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