DEVICE: AXS Catalyst 6 (07613327012033)
Device Identifier (DI) Information
AXS Catalyst 6
M003IC0601320
In Commercial Distribution
IC060132
Stryker Corporation
M003IC0601320
In Commercial Distribution
IC060132
Stryker Corporation
Distal Access Catheter
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Vascular guide-catheter, single-use | A sterile, flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, is not a microcatheter (i.e., not intended to access superselective small vessels), and does not include a transseptal needle. It may include a disposable percutaneous introduction set. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DQY | CATHETER, PERCUTANEOUS |
NRY | CATHETER, THROMBUS RETRIEVER |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K151667 | 000 |
K173841 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in cool, dry, dark place. |
Clinically Relevant Size
[?]Size Type Text |
---|
Lumen/Inner Diameter: 0.06 Inch |
Length: 132.0 Centimeter |
Device Record Status
5b457013-217f-4ae4-a199-1858b80f8c1c
January 23, 2019
6
September 21, 2016
January 23, 2019
6
September 21, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(855)916-3876
NVCustomerService@stryker.com
NVCustomerService@stryker.com