510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062569Substantially Equivalent

Safeguard 24 Cm Pressure Assisted Dressing

Datascope Corp., Manwah NJ / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062569 is the FDA 510(k) clearance record for SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING, a class II device, cleared for Datascope Corp. on under FDA product code DXC (Clamp, Vascular). FDA records list 139 510(k) clearances for Datascope Corp., from to . As of , FDA records show no recalls naming K062569.

Clearance record

Decision date
Received
(167 days to decision)
Product code
DXC Clamp, Vascular
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Datascope Corp. 1300 Macarthur Blvd., Manwah NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXC

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