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510(k) K862412

INTESTOPLANT by Burron Medical Products, Inc. — Product Code LLD

K862412 is an FDA 510(k) premarket notification submitted by Burron Medical Products, Inc. for the device "INTESTOPLANT". The FDA issued a decision of Substantially Equivalent on November 13, 1986. The device falls under product code LLD (Port & Catheter, Implanted, Subcutaneous, Intraperitoneal), a Class II device regulated under 21 CFR 880.5965. Burron Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1986
Date Received
June 25, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Port & Catheter, Implanted, Subcutaneous, Intraperitoneal
Device Class
Class II
Regulation Number
880.5965
Review Panel
HO
Submission Type

Other clearances by Burron Medical Products, Inc.

  • K870403 — CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE (May 1, 1987)
  • K861479 — CAVAFIX, CENTRAL VENOUS CATHETER KIT (July 1, 1986)
  • K860126 — STIMUPLEX, NERVE STIMULATOR (February 28, 1986)
  • K851293 — IMPLANTOFIX (January 9, 1986)
  • K841428 — JEJUNOSTOMY SET FOR TUBE FEEDING (July 9, 1984)
  • K834383 — DUAL-LUMEN LONG TERM CENTRAL VENOUS CAT (May 1, 1984)
  • K834299 — LONG TERM CENTRAL VENOUS ACCESS CATH (May 1, 1984)
  • K834473 — MULTI-LUMEN CENTRAL VENOUS CATH. KIT (April 30, 1984)
  • K840179 — CONTINUOUS EPIDURAL ANESTHES. TRAY (February 24, 1984)
  • K840287 — BRACHIAL PLEXUS ANESTHESIA TRAY (February 23, 1984)

Other clearances for product code LLD

  • K880072 — PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM (March 29, 1988)
  • K864552 — PORT-A-CATH IMPLANTABLE CATHETER SYSTEM (March 31, 1987)
  • K832906 — PORT-A-CATH IMPLANTABLE CATHETER SYS (March 6, 1984)

FDA data resources