510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN200062Unknown

Parsortix PC1 Device

Angle Europe, Ltd., Guildford, GB / Direct, Unknown
FDA source (opens on fda.gov)

DEN200062 is the FDA 510(k) clearance record for Parsortix PC1 Device, a class II device, cleared for Angle Europe , Ltd. on under FDA product code QSA (Circulating Tumor Cell (Ctc) Enrichment Device). FDA's definition for product code QSA reads: "A circulating tumor cell enrichment device is an in vitro diagnostic device used to enrich circulating tumor cells from the peripheral blood of patients diagnosed with cancer for subsequent in vitro diagnostic testing". FDA records list one 510(k) clearance for Angle Europe , Ltd. As of , FDA records show no recalls naming DEN200062.

Clearance record

Decision date
Received
(603 days to decision)
Product code
QSA Circulating Tumor Cell (Ctc) Enrichment Device
Regulation
21 CFR 866.6110
Device class
Class II
Review panel
Immunology
Applicant
Angle Europe , Ltd. 10 Nugent Rd., Guildford, GB
Third party review
No

Clearances, product code QSA

Trailing 12 months

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

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