510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062126Substantially Equivalent

Embocath Plus Infusion Microcatheter, Model Ecp-100 and Ecp-135

Biosphere Medical, S.A., Rockland MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062126 is the FDA 510(k) clearance record for EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135, a class II device, cleared for Biosphere Medical, Inc. on under FDA product code DQO (Catheter, Intravascular, Diagnostic). FDA records list 18 510(k) clearances for Biosphere Medical, Inc., from to . As of , FDA records show no recalls naming K062126.

Clearance record

Decision date
Received
(14 days to decision)
Product code
DQO Catheter, Intravascular, Diagnostic
Regulation
21 CFR 870.1200
Device class
Class II
Review panel
Cardiovascular
Applicant
Biosphere Medical, Inc. 1050 Hingham St., Rockland MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQO

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