FDA.reportPublic FDA data

Pulmonary Wedge Pressure Catheter

Primary DI
20613994733652
Brand
Pulmonary Wedge Pressure Catheter
Company
MEDTRONIC, INC.
Model
150075
Device description
ACCSY 150075 PULM WEDGE PRESS MONITOR5PK
Published
2016-06-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQOCATHETER, INTRAVASCULAR, DIAGNOSTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K884065000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K884065000CATH LAB MONITORING CATHETERC.R. Bard, Inc.1989-01-12DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613994733652PackageGS15In Commercial Distribution
00613994733658PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061399473365220613994733652
00613994733658006139947336586139947336580613994733658

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary artery catheter, standardA flexible tube with an inflatable balloon at its distal tip designed to be introduced percutaneously into the venous system via a central vein (e.g., jugular, subclavian) and advanced from the superior vena cava to the pulmonary artery, to measure/monitor a haematological parameter(s) (e.g., pulmonary arterial pressures, continuous cardiac output, stroke volume) via the pressure changes at its distal tip; it is not intended to be used for thermal dilution techniques. Also referred to as a Swan-Ganz catheter, it is typically used in conjunction with a parent device (e.g., external blood pressure transducer) and may include devices dedicated to introduction. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge7French
Length110Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Storage - in a cool, dry, dark place with protective sheaths fitted over balloons as protection against the atmosphere and fluorescent, ultraviolet and/or incandescent light.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00824846001041NABB12W64R2026-06-08
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00643169530102ATTAIN CLARITY™62252016-07-16
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