FDA.reportPublic FDA data

Catheter Passer

Primary DI
00763000031411
Brand
Catheter Passer
Company
MEDTRONIC PS MEDICAL, INC.
Model
8591-60
Device description
PASSER 8591-60 CATHETER-60CM
Published
2020-01-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAJCatheter, percutaneous, intraspinal, short term

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAJCatheter, Percutaneous, Intraspinal, Short TermAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K911382000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K911382000IPI ALGO-LINE CATHETERPudenz-Schulte Medical Research Corp.1991-07-18MAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000031411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000031411007630000314117630000314110763000031411

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous tunneller, single-useA sterile, hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
089055867
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000029449N/A8023 B2020-03-07
00763000030827N/A250772020-03-08
00643169483316NA8023 B2015-06-24
00643169498365NA250772015-07-14
00643169507517NA8023 A2015-06-25
00643169073623NA250772015-06-25
00643169466142N/A461412015-07-15
00673978228969NA464222015-06-18
00673978246017NA272972015-07-21
00673978246031NA273022015-07-14
20643169466122N/A464402015-07-15
00763000422646StrataMR246955MR2026-03-13
00763000422684StrataMR246957MR2026-03-13
00673978226835NA8591-602015-11-25
00643169497955Clear-Site®469182015-09-16
00613994450661Clear-Site®469182015-07-16
00763000422660StrataMR II46956MR2025-05-02
00763000422653Valve, StrataMR II, Regular46965MR2025-01-23
00763000422677Snap Shunt Assembly, StrataMR II, Regular46966MR2025-01-23
00763000422691Unassembled Shunt Kit, StrataMR II, Regular46967MR2025-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000027841Catheter PasserMEDTRONIC PS MEDICAL, INC.MAJ2020-04-03
00763000027858Catheter PasserMEDTRONIC PS MEDICAL, INC.MAJ2020-04-02
00763000031404Catheter PasserMEDTRONIC PS MEDICAL, INC.MAJ2020-01-27
00643169466326Cathter Passer, DisposableMEDTRONIC PS MEDICAL, INC.MAJ2016-06-17
00673978230467NAMEDTRONIC PS MEDICAL, INC.MAJ2015-12-03
00673978226828NAMEDTRONIC PS MEDICAL, INC.MAJ2015-11-25
00673978226835NAMEDTRONIC PS MEDICAL, INC.MAJ2015-11-25
00673978226842NAMEDTRONIC PS MEDICAL, INC.MAJ2015-11-25
00673978226859NAMEDTRONIC PS MEDICAL, INC.MAJ2015-11-25
00673978230436NAMEDTRONIC PS MEDICAL, INC.MAJ2015-11-24
00643169466319NAMEDTRONIC PS MEDICAL, INC.MAJ2015-07-21
00613994840295NAMEDTRONIC PS MEDICAL, INC.MAJ2015-07-21