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510(k) K860806

REGULATED PRESSURE INJECTOR by Target Therapeutics — Product Code DXF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1986
Date Received
March 4, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Septostomy
Device Class
Class II
Regulation Number
870.5175
Review Panel
CV
Submission Type

Other clearances by Target Therapeutics

  • K964488 — DETACHABLE SILICONE BALLOON (DSB) (April 21, 1998)
  • K965071 — DETACHABLE SLICONE BALLOON (DSB) (April 21, 1998)
  • K964210 — RETRIEVER II (October 31, 1997)
  • K971395 — GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LI (July 14, 1997)
  • K965189 — SPINNAKER (March 24, 1997)
  • K964112 — BERENSTEIN COIL (February 26, 1997)
  • K963307 — GDC PATIENT RETURN ELECTTRODE MODEL 45021 (December 17, 1996)
  • K962503 — GUGLIELMI DETACHABLE COIL (September 20, 1996)
  • K961923 — BERENSTEIN COIL (August 15, 1996)
  • K960705 — GUGLIELMI DETACHABLE COIL (May 21, 1996)

Other clearances for product code DXF

  • K253799 — SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135 (March 13, 2026)
  • K260292 — HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) (February 27, 2026)
  • K252419 — HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) (August 27, 2025)
  • K251007 — CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW (May 1, 2025)
  • K243193 — Cross Wise™ Multi-Use RF Adapter Cable (November 26, 2024)
  • K242076 — VersaCross™ RF Wire (November 1, 2024)
  • K241414 — CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, C (September 26, 2024)
  • K240900 — HOTWIRE™ RF Guidewire (May 1, 2024)
  • K232852 — Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable (October 12, 2023)
  • K221528 — Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Cathet (August 22, 2022)