510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K970485Substantially Equivalent

Smartsite Access Pin

Ivac Medical Systems, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970485 is the FDA 510(k) clearance record for SMARTSITE ACCESS PIN, a class II device, cleared for Ivac Medical Systems on under FDA product code FPA (Set, Administration, Intravascular). FDA records list 2 510(k) clearances for Ivac Medical Systems, from to . As of , FDA records show 3 recalls naming K970485.

Clearance record

Decision date
Received
(70 days to decision)
Product code
FPA Set, Administration, Intravascular
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Ivac Medical Systems 10221 Wateridge Cir., San Diego CA
510(k) summary
Summary
Third party review
No

Clearances, product code FPA

Trailing 12 months
5 clearances under product code FPA in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FPA, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260