Home / 510(k) Clearances / K801261

510(k) K801261

DISPOSABLE COUPLING ADAPTOR by Intec Medical, Inc. — Product Code BYX

K801261 is an FDA 510(k) premarket notification submitted by Intec Medical, Inc. for the device "DISPOSABLE COUPLING ADAPTOR". The FDA issued a decision of Substantially Equivalent on June 9, 1980. The device falls under product code BYX (Tubing, Pressure And Accessories), a Class I device regulated under 21 CFR 868.5860. Intec Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1980
Date Received
May 28, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Pressure And Accessories
Device Class
Class I
Regulation Number
868.5860
Review Panel
AN
Submission Type

Other clearances by Intec Medical, Inc.

  • K911840 — INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER (June 3, 1991)
  • K903216 — THE GUIDER CORONARY GUIDING CATHETER (October 19, 1990)
  • K903217 — TAPERED TIP THE GUIDER CORONARY GUIDING CATHETER (October 19, 1990)
  • K900710 — INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER (October 19, 1990)
  • K903840 — GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY (October 16, 1990)
  • K903906 — PERCUTANEOUS CATHETER INTRODUCER KIT (September 26, 1990)
  • K900998 — INTERVENTIONAL MEDICAL Y ADAPTER W/ADJUST. VALVE (August 14, 1990)
  • K901247 — TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES (July 31, 1990)
  • K894925 — AMCATH URETERAL DILATORS MODELS 7100,7110,7120 (December 13, 1989)
  • K860941 — DISPOSABLE HEATED WIRE LOOPS 48 AND 72 (April 2, 1986)

Other clearances for product code BYX

  • K011134 — OXYGEN SUPPLY TUBING, MODEL 1115 (June 13, 2001)
  • K955656 — NORTH STATE PLASTICS AEROSOL TEE (March 6, 1996)
  • K943110 — GAS SAMPLING INTERFACES (August 19, 1994)
  • K935835 — BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES (January 12, 1994)
  • K931033 — MF CHEMETRON STYLE MEDICAL GAS WALL OUTLETS (June 1, 1993)
  • K931043 — MF OHMEDA STYLE MEDICAL GAS WALL OUTLETS (June 1, 1993)
  • K913422 — OXYGEN TUBING, 81503 (January 30, 1992)
  • K914980 — HEX, QUAD, OR RAIL BLOCK MANIFOLD ACCESSORIES (January 21, 1992)
  • K912763 — OHMEDA STYLE CHECK UNITS (FEMALE COUPLERS) (October 15, 1991)
  • K905091 — VARIOUS MALE QUICK CONNECTS. (March 4, 1991)

FDA data resources