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510(k) K970341

MEDTRONIC PS MEDICAL RIVAS VASCULAR CATHETER REPAIR KIT by Medtronic PS Medical — Product Code LIS

K970341 is an FDA 510(k) premarket notification submitted by Medtronic PS Medical for the device "MEDTRONIC PS MEDICAL RIVAS VASCULAR CATHETER REPAIR KIT". The FDA issued a decision of Substantially Equivalent on April 23, 1997. Medtronic PS Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1997
Date Received
January 29, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Medtronic PS Medical

  • K012052 — MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855 (February 11, 2002)
  • K010361 — MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900 (May 7, 2001)
  • K010487 — BIPOLAR PENCIL, MODEL 3901-002, 3900-002 (May 3, 2001)
  • K010341 — MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2 (April 20, 2001)
  • K003914 — MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES (February 22, 2001)
  • K002572 — MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002, 2232-003 (November 16, 2000)
  • K991502 — MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022 (September 12, 2000)
  • K990333 — MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3 (April 28, 1999)
  • K984053 — BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM (February 4, 1999)
  • K983799 — MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAG (January 26, 1999)

FDA data resources