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510(k) K771986

CATHETER, MEDIASTINAL&PERICARDIAL by The Minnesota Back Brace Co. — Product Code FHF

K771986 is an FDA 510(k) premarket notification submitted by The Minnesota Back Brace Co. for the device "CATHETER, MEDIASTINAL&PERICARDIAL". The FDA issued a decision of Substantially Equivalent on October 28, 1977. The device falls under product code FHF (System, Evacuator, Fluid), a Class II device regulated under 21 CFR 876.4370.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1977
Date Received
October 19, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Evacuator, Fluid
Device Class
Class II
Regulation Number
876.4370
Review Panel
GU
Submission Type

Other clearances for product code FHF

  • K093479 — DISPOSABLE SUCTION AND IRRIGATION SYSTEM (May 19, 2010)
  • K003443 — SUCTION IRRIGATOR (February 1, 2001)

FDA data resources