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510(k) K960937

SUCTION SAFETY DEVICE by R D Intl. — Product Code MJJ

K960937 is an FDA 510(k) premarket notification submitted by R D Intl. for the device "SUCTION SAFETY DEVICE". The FDA issued a decision of Substantially Equivalent on June 5, 1996. The device falls under product code MJJ (Cpb Check Valve, Retrograde Flow, In-Line), a Class II device regulated under 21 CFR 870.4400. R D Intl. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1996
Date Received
March 8, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cpb Check Valve, Retrograde Flow, In-Line
Device Class
Class II
Regulation Number
870.4400
Review Panel
CV
Submission Type

Other clearances by R D Intl.

  • K960312 — RDI CARDIAC INSULATION PAD (April 19, 1996)

Other clearances for product code MJJ

  • K182442 — MiniGuard Arterial Safety Valve (November 6, 2018)
  • K142500 — One Way Soft Valve (January 29, 2015)
  • K001245 — 3T L. V. CONTROL VALVE (August 15, 2001)
  • K992785 — IBC FLOGUARD, MODEL 6050 (January 14, 2000)
  • K982406 — COBE VACUUM RELIEF CHECK VALVE (October 7, 1998)
  • K922781 — FLOW CONROL VALVE (March 8, 1993)
  • K922356 — FLOW CONTROL VALVE, CAT. NO. ACV-38 (February 12, 1993)
  • K921500 — CENTRI-SAFE(TM) VALVE (September 15, 1992)

FDA data resources