FDA.reportPublic FDA data

FemoStop™

Primary DI
15414734050033
Brand
FemoStop™
Company
ST. JUDE MEDICAL, INC.
Model
Gold
Catalog number
C11165
Device description
Femoral Compression System
Published
2016-04-19
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
DXCCLAMP, VASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110193000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110193000FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; FSt. Jude Medical Systems AB2011-02-24DXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15414734050033PackageGS110In Commercial Distribution
05414734050036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1541473405003315414734050033
05414734050036054147340500365414734050036

GMDN Terms#

Term, Definition table
TermDefinition
Femoral artery compression system, single-useAn assembly of sterile devices intended to be used in conjunction with manual compression to facilitate haemostasis to the puncture site on a patient having undergone femoral artery catheterization. It typically consists of a dedicated catheter with an elastomeric membrane at the distal tip and a tensioner. The catheter is inserted through the previously placed catheter introducer sheath and, once positioned, the membrane is deployed in the inner lumen of the femoral artery. Tension is applied to keep the membrane against the arteriotomy while the natural mechanisms of haemostasis are enacted. Once haemostasis is achieved, this device is removed. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry. Do not use if package is damaged.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
149818952
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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05415067032201EnSite™ENSITE-R-FF-01ENSITE-R-FF-012021-01-06
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05415067055668EnSite™ENSITE-D-PI-01ENSITE-D-PI-012026-08-19
05415067055675EnSite™ENSITE-PI-01ENSITE-PI-012026-08-19
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