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510(k) K992476

PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS by Pilling Weck Surgical — Product Code MWS

K992476 is an FDA 510(k) premarket notification submitted by Pilling Weck Surgical for the device "PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS". The FDA issued a decision of Substantially Equivalent on September 13, 2000. The device falls under product code MWS (Stabilizer, Heart), a Class I device regulated under 21 CFR 870.4500. Pilling Weck Surgical has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2000
Date Received
July 26, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stabilizer, Heart
Device Class
Class I
Regulation Number
870.4500
Review Panel
CV
Submission Type

Other clearances by Pilling Weck Surgical

  • K992174 — PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP (March 23, 2000)
  • K990935 — JACKSON ESOPHAGEAL DILATOR (May 17, 1999)
  • K990561 — OPTICAL FORCEPS (May 14, 1999)
  • K982128 — SHIKANI-FRENCH SPEAKING VALVE (October 23, 1998)

Other clearances for product code MWS

  • K041338 — MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES (July 19, 2004)
  • K992833 — VACUUM ASSIST STABILIZER (November 10, 1999)
  • K982419 — HEART-LIFT BALLOON POSITIONER (January 13, 1999)

FDA data resources