510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851825Substantially Equivalent

Scanlan Tunneler, Sheath & Tip

Scanlan Intl., Inc., Saint Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851825 is the FDA 510(k) clearance record for SCANLAN TUNNELER, SHEATH & TIP, a class I device, cleared for Scanlan Intl., Inc. on under FDA product code DWS (Instruments, Surgical, Cardiovascular). FDA records list 19 510(k) clearances for Scanlan Intl., Inc., from to . As of , FDA records show no recalls naming K851825.

Clearance record

Decision date
Received
(77 days to decision)
Product code
DWS Instruments, Surgical, Cardiovascular
Regulation
21 CFR 870.4500
Device class
Class I
Review panel
Cardiovascular
Applicant
Scanlan Intl., Inc. One Scanlan Plz., Saint Paul MN
Third party review
No

Clearances, product code DWS

Trailing 12 months

FDA records hold no clearances under product code DWS in the trailing twelve months.

FDA records show no clearances under product code DWS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DWS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260