FDA.reportPublic FDA data

VALVULOTOME (DETACHABLE TYPE)

Primary DI
14953170047692
Brand
VALVULOTOME (DETACHABLE TYPE)
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
C-0104B
Device description
VALVULOTOME (DETACHABLE TYPE)
Published
2016-09-21
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWXSTRIPPER, ARTERY, INTRALUMINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWXStripper, Artery, IntraluminalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K895878000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895878000OLYMPUS VALVULOTOME W/DETACHABLE TIPOlympus Corp.1990-01-02DWX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170047692PackageGS11In Commercial Distribution
04953170047695PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317004769214953170047692
04953170047695049531700476954953170047695

GMDN Terms#

Term, Definition table
TermDefinition
ValvulotomeA hand-held manual surgical instrument designed for cutting an anatomical valve or valves in situ (e.g., to slit a heart valve or to cut the valves within a vein to allow blood flow in the opposite direction). It is typically a flexible, plastic-coated metal shaft with a proximal handle and an extremely sharp cutting edge at the distal tip (e.g., the distal tip may terminate in a blade which is curved at 90 degrees to the shaft, or an assembly of several thin helicoidal blades that are rotated). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
711789789
Device count
1
DM exempt
true
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170158759DISPOSABLE HOT BIOPSY FORCEPSFD-210U2016-09-21
04953170158766DISPOSABLE HOT BIOPSY FORCEPSFD-230U2016-09-21
04953170354236DISPOSABLE HOT BIOPSY FORCEPSFD-210UN53565302016-09-21
04953170354243DISPOSABLE HOT BIOPSY FORCEPSFD-230UN53566302016-09-21
04953170214288RECORDER UNIT HARNESSMAJ-1475N24838302023-06-21
04953170331718Light guideOCS5-LG2016-09-21
04953170333316RECORDER HOLDERMAJ-2033N44720302016-09-21
04953170467592DISPOSABLE BIOPSY FORCEPSFB-211DN54318422026-04-09
04953170467608DISPOSABLE BIOPSY FORCEPSFB-221DN54319422026-04-09
04953170467615DISPOSABLE BIOPSY FORCEPSFB-231DN54320422026-04-09
04953170467622DISPOSABLE BIOPSY FORCEPSFB-241DN54321422026-04-09
04953170466038Single Use Electrosurgical Hemostatic ForcepsFD-410LRN10861412026-04-01
04953170466182Single Use Electrosurgical Hemostatic ForcepsFD-411URN30463402026-04-01
04953170466267Single Use Electrosurgical Hemostatic ForcepsFD-412LRN53686402026-04-01
04953170035647ELECTROSURGICAL SNARESD-5L-12016-09-21
04953170035708ELECTROSURGICAL SNARESD-5U-12016-09-21
04953170035838ELECTROSURGICAL SNARESD-6U-12016-09-21
04953170035951ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170035968ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170036033ELECTROSURGICAL SNARESD-8P-12016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000358822NAMEDTRONIC, INC.DWX2020-02-17
10885403034992V. MuellerCAREFUSION 2200, INCDWX2016-09-23
04953170047671VALVULOTOME (DETACHABLE TYPE)OLYMPUS MEDICAL SYSTEMS CORP.DWX2016-09-21
04953170047695VALVULOTOME (DETACHABLE TYPE)OLYMPUS MEDICAL SYSTEMS CORP.DWX2016-09-21
14953170047678VALVULOTOME (DETACHABLE TYPE)OLYMPUS MEDICAL SYSTEMS CORP.DWX2016-09-21
24026704518955PILLINGTELEFLEX INCORPORATEDDWX2016-09-16
24026704518962PILLINGTELEFLEX INCORPORATEDDWX2016-09-16
04026704518944PillingTELEFLEX INCORPORATEDDWX2016-09-16
04026704518951PillingTELEFLEX INCORPORATEDDWX2016-09-16
04026704518968PillingTELEFLEX INCORPORATEDDWX2016-09-16
00840663102693MollRing Cutter Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663102709MollRing Cutter Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663102716MollRing Cutter Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663102723MollRing Cutter Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663102730MollRing Cutter Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663102747MollRing Cutter Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105823MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105830MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105847MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105854MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105861MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105878MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105885MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105892MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105908MultiTASC Dissection/Transection Device sizing toolLemaitre Vascular, Inc.DWX2015-07-15
00840663102563Periscope DissectorLemaitre Vascular, Inc.DWX2015-06-30
00840663102570Martin DissectorLemaitre Vascular, Inc.DWX2015-06-30
00840663102587EndoHelix Retrieval DeviceLemaitre Vascular, Inc.DWX2015-06-30