510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K091760Substantially Equivalent

Dermaport Ported Vascular Access System (Pvas)

Dermaport, Inc., Santa Clarita CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091760 is the FDA 510(k) clearance record for DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS), a class II device, cleared for Dermaport, Inc. on under FDA product code MSD (Catheter, Hemodialysis, Implanted). FDA records list 2 510(k) clearances for Dermaport, Inc., from to . As of , FDA records show no recalls naming K091760.

Clearance record

Decision date
Received
(34 days to decision)
Product code
MSD Catheter, Hemodialysis, Implanted
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Dermaport, Inc. 25102 Rye Canyon Loop, Santa Clarita CA
510(k) summary
Summary PDF
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