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510(k) K841412

ROLLED NECK W/TAP by Warne Surgical Products, Ltd. — Product Code BTC

K841412 is an FDA 510(k) premarket notification submitted by Warne Surgical Products, Ltd. for the device "ROLLED NECK W/TAP". The FDA issued a decision of Substantially Equivalent on April 18, 1984. The device falls under product code BTC (Bag, Reservoir), a Class I device regulated under 21 CFR 868.5320. Warne Surgical Products, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1984
Date Received
April 5, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bag, Reservoir
Device Class
Class I
Regulation Number
868.5320
Review Panel
AN
Submission Type

Other clearances by Warne Surgical Products, Ltd.

  • K850696 — WSP CODE 4300 DIOMASTER DIAGNOSTIC (May 17, 1985)
  • K850694 — WSP CODE 4310 STRESSCATH (May 17, 1985)
  • K850695 — WSP CODE 4301 DIOMASTER THERAPEUTIC (May 16, 1985)
  • K850693 — WSP CODE 4315 PADTEST (May 10, 1985)
  • K841511 — HAEMATURIA CATHETERS (July 12, 1984)
  • K840687 — KIDNEY TRANSPLANT CATHETER (June 7, 1984)
  • K841411 — ROLLED NECK W/PLUG (April 18, 1984)
  • K841409 — BUSH NECK W/PLUG (April 18, 1984)
  • K841410 — BUSH NECK W/TAP (April 18, 1984)
  • K840702 — SECURE W/25MM DIAM. SHEATH & ADHESIVE (March 22, 1984)

Other clearances for product code BTC

  • K181424 — PeDIA (September 25, 2018)
  • K940220 — REBREATHER BAGS (May 27, 1994)
  • K932581 — BREATHING BAGS (July 16, 1993)
  • K932496 — PRECISION MED PRODUCTS, LTD. BREATHING BAGS (July 16, 1993)
  • K932584 — BREATHING BAGS (July 16, 1993)
  • K932191 — BREATHING BAGS (July 2, 1993)
  • K894906 — ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER (September 18, 1989)
  • K880680 — KING SYSTEMS, BREATHING BAG (March 3, 1988)
  • K864822 — VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS (January 15, 1987)
  • K841411 — ROLLED NECK W/PLUG (April 18, 1984)

FDA data resources