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Found 5 results
510(k) Data Aggregation
K Number
K992476Device Name
PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS
Manufacturer
PILLING WECK SURGICAL
Date Cleared
2000-09-13
(415 days)
Product Code
MWS, MMS
Regulation Number
870.4500Why did this record match?
Applicant Name (Manufacturer) :
PILLING WECK SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Heart Stabilizer Pad is used on an appropriate heart stabilizer unit for coronary bypass surgery. It provides a mechanical means for immobilization of the anastomotic site on a beating heart and provides coronary artery isolation and occlusion by compression.
Device Description
Pilling Weck Surgical Stabilizer Removable Pads
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K Number
K992174Device Name
PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP
Manufacturer
PILLING WECK SURGICAL
Date Cleared
2000-03-23
(269 days)
Product Code
DXC
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
PILLING WECK SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aortic Spoon Jaw Clamp is for use in the coronary bypass operations without application of an aortic clamp. It provides a mechanical means to isolate a 10 x 8mm area of the aortic wall from blood flow.
Device Description
Aortic Spoon Jaw Clamp
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K Number
K990935Device Name
JACKSON ESOPHAGEAL DILATOR
Manufacturer
PILLING WECK SURGICAL
Date Cleared
1999-05-17
(59 days)
Product Code
KNQ
Regulation Number
876.5365Why did this record match?
Applicant Name (Manufacturer) :
PILLING WECK SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used for exploratory and dilation of strictures of the esophagus. Designed to be used in conjunction with an appropriate size rigid esophagascope.
Device Description
Device consists of silicone tip, stainless steel rod and nylon sleeve.
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K Number
K990561Device Name
OPTICAL FORCEPS
Manufacturer
PILLING WECK SURGICAL
Date Cleared
1999-05-14
(81 days)
Product Code
JEK, EOX, EWY
Regulation Number
874.4680Why did this record match?
Applicant Name (Manufacturer) :
PILLING WECK SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used for Tracheobronchial or Esophageal foreign body removal or biopsy procedures. To be used through rigid scopes: Bronchoscopes, Esophagoscopic, Laryngoscopes and Mediastinoscopes
Device Description
The Optical Forcep consists of two components - a. Telescope - b. Biopsy Forcep
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K Number
K982128Device Name
SHIKANI-FRENCH SPEAKING VALVE
Manufacturer
PILLING WECK SURGICAL
Date Cleared
1998-10-23
(128 days)
Product Code
JOH
Regulation Number
868.5800Why did this record match?
Applicant Name (Manufacturer) :
PILLING WECK SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To allow airflow over the vocal cords for speaking To be used only as an attachment to CLJackson improved function. trachea tubes, manufactured by Pilling Weck Surgical.
Device Description
The Shikani-French Speaking Valve consists of a plastic outer body and a captured inner ball that forms the check valve. The assembly attaches to the C.L. Jackson Improved Stainless Steel Trachea Tube. Once in place, the valve allows the patient to inhale through the tracheostomy tube and exhale across the vocal chords which facilitates speak.
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