OptiCross 35 H7493932800350

GUDID 08714729984542

Peripheral Imaging Catheter

BOSTON SCIENTIFIC CORPORATION

Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use
Primary Device ID08714729984542
NIH Device Record Key5e5222ad-5403-428c-9b6d-ad76e39cb12a
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptiCross 35
Version Model NumberH7493932800350
Catalog NumberH7493932800350
Company DUNS021717889
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French

Device Identifiers

Device Issuing AgencyDevice ID
GS108714729984542 [Primary]
GS108714729984542 [Primary]
GS108714729984542 [Primary]
GS108714729984542 [Primary]
GS108714729984542 [Primary]
GS108714729984542 [Primary]
GS108714729984542 [Primary]
GS108714729984542 [Primary]
GS108714729984542 [Primary]
GS108714729984542 [Primary]
GS108714729984542 [Primary]
GS108714729984542 [Primary]
GS108714729984542 [Primary]
GS108714729984542 [Primary]
GS108714729984542 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic
ITXTransducer, ultrasonic, diagnostic
ITXTransducer, ultrasonic, diagnostic
ITXTransducer, ultrasonic, diagnostic
ITXTransducer, ultrasonic, diagnostic
ITXTransducer, ultrasonic, diagnostic
ITXTransducer, ultrasonic, diagnostic
ITXTransducer, ultrasonic, diagnostic
ITXTransducer, ultrasonic, diagnostic
ITXTransducer, ultrasonic, diagnostic
ITXTransducer, ultrasonic, diagnostic
ITXTransducer, ultrasonic, diagnostic
ITXTransducer, ultrasonic, diagnostic
ITXTransducer, ultrasonic, diagnostic
ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-23
Device Publish Date2020-06-15

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

08714729984542 - OptiCross 352020-06-23Peripheral Imaging Catheter
08714729984542 - OptiCross 352020-06-23 Peripheral Imaging Catheter
08714729994183 - SpyGlass™ Discover2020-06-12 Digital Catheter
08714729998723 - SpyGlass™ Discover2020-06-12 Digital Controller
08714729998754 - SpyGlass™ Discover2020-06-12 Digital Controller
08714729802327 - Blazer Prime® XP2020-06-11 Temperature Ablation Catheter
08714729802334 - Blazer Prime® XP2020-06-11 Temperature Ablation Catheter
08714729802341 - Blazer Prime® XP2020-06-11 Temperature Ablation Catheter
08714729802358 - Blazer Prime® XP2020-06-11 Temperature Ablation Catheter

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.