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510(k) K873332

MAXIVAC(TM) CLOSED WOUND SUCTION DRAINAGE SYSTEM by American V. Mueller — Product Code GCY

K873332 is an FDA 510(k) premarket notification submitted by American V. Mueller for the device "MAXIVAC(TM) CLOSED WOUND SUCTION DRAINAGE SYSTEM". The FDA issued a decision of Substantially Equivalent on September 8, 1987. The device falls under product code GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered), a Class I device regulated under 21 CFR 878.4680. American V. Mueller has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1987
Date Received
August 19, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device Class
Class I
Regulation Number
878.4680
Review Panel
SU
Submission Type

Other clearances by American V. Mueller

  • K873771 — HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO (December 18, 1987)
  • K871685 — HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS (June 12, 1987)
  • K864676 — HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM (December 29, 1986)
  • K862772 — V. MUELLER (R) GOOSENECK CIRCULAR STAPLER (August 18, 1986)
  • K861471 — V. MUELLER VITAL CLIP-HEMOSTATIC CLIP (June 6, 1986)
  • K854568 — V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP (December 2, 1985)
  • K854049 — HEYER-SCHULTE SYRINGO PERITONEAL SHUNT (November 27, 1985)
  • K851082 — V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES (July 22, 1985)
  • K851974 — V. MUELLER VITAL SKIN STAPLER (June 11, 1985)
  • K850947 — V-MUELLER INVERTED LINEAR ANASTOMOSIS INSTRUMENTS (April 17, 1985)

Other clearances for product code GCY

  • K972703 — REDYROB-CLOSED WOUND DRAINAGE SYSTEM (October 1, 1997)
  • K971036 — ODONTIT AUTOGENOUS BONE COLLECTION DEVICE (June 3, 1997)
  • K963839 — CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500 (December 12, 1996)
  • K960099 — PENROSE DRAIN MODELS 6001 - 6007 (March 11, 1996)
  • K950754 — MACRO SUCTION TUBE MODEL NO 10061 (April 25, 1995)
  • K936223 — PRESSURE IRRIGATING SYSTEM (May 12, 1994)
  • K930615 — AUTOVAC CLOSED WOUND SUCTION SYSTEM (February 22, 1994)
  • K933319 — BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTE (October 27, 1993)
  • K933306 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES (October 5, 1993)
  • K933305 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE (October 5, 1993)

FDA data resources