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510(k) K840305

CATEGORY 1 CIRCULATORY SYSTEM DEVICE by Imm Enterprises , Ltd. — Product Code DWS

K840305 is an FDA 510(k) premarket notification submitted by Imm Enterprises , Ltd. for the device "CATEGORY 1 CIRCULATORY SYSTEM DEVICE". The FDA issued a decision of Substantially Equivalent on April 23, 1984. The device falls under product code DWS (Instruments, Surgical, Cardiovascular), a Class I device regulated under 21 CFR 870.4500. Imm Enterprises , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1984
Date Received
January 24, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instruments, Surgical, Cardiovascular
Device Class
Class I
Regulation Number
870.4500
Review Panel
CV
Submission Type

Other clearances by Imm Enterprises , Ltd.

  • K841387 — WESTON RECTAL SNARE (May 9, 1984)
  • K841386 — KOLLMANN URETHRAL DILATOR (May 9, 1984)
  • K840311 — CAT. 7-EAR, NOSE & THROAT DEVICES (May 9, 1984)
  • K840304 — CATEGORY 17-MICROBIOLOGY DEVICES (May 1, 1984)
  • K840318 — CAT. 14-CLINICAL TOXIOLOGY DEVICES (April 23, 1984)
  • K840312 — CAT. 8 DENTAL DEVICES (April 5, 1984)
  • K834171 — OP-CON SURG. INSTRUMENT #3 (April 4, 1984)
  • K834191 — JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 (March 22, 1984)
  • K834192 — JAKOBI SURG. INSTRUMENTS #3 21/22/24 (March 22, 1984)
  • K840310 — CATEGORY 6 OPTHALMIC DEVICES (March 16, 1984)

Other clearances for product code DWS

  • K022238 — MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 (October 9, 2002)
  • K964445 — OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) (January 30, 1997)
  • K962771 — BURKE CONGENITAL THORACOSCOPY INSTRUMENTS (November 19, 1996)
  • K955689 — RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY (May 15, 1996)
  • K960139 — G.E. STERILE ANGIOGRAPHIC TRAY (April 19, 1996)
  • K960144 — G.E. STERILE CT BIOPSY TRAY (April 15, 1996)
  • K960143 — G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY (April 9, 1996)
  • K934727 — REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER (January 10, 1994)
  • K900379 — HYCULT DIAMOND CORONARY BYPASS KNIFE (March 19, 1990)
  • K896307 — INSULATION PAD (January 19, 1990)

FDA data resources