510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001633Substantially Equivalent

Lifesite Hemodialysis Access System/cannula Exchange, Model Lhas14120 & Lhcek0000

Vasca, Inc., Tewksburt MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001633 is the FDA 510(k) clearance record for LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS14120 & LHCEK0000, a class II device, cleared for Vasca, Inc. on under FDA product code MSD (Catheter, Hemodialysis, Implanted). FDA records list 2 510(k) clearances for Vasca, Inc., from to . As of , FDA records show one recall naming K001633.

Clearance record

Decision date
Received
(90 days to decision)
Product code
MSD Catheter, Hemodialysis, Implanted
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Vasca, Inc. 3 Highwood Dr., Tewksburt MA
510(k) summary
Summary
Third party review
No

Clearances, product code MSD

Trailing 12 months

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

FDA records show no clearances under product code MSD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MSD, 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