Atlas FDA

Reprocesses Umbilical Cable

FDA 510(k) clearance K221854 · decided 2022-08-06

Clearance details

K-number
K221854
Device name
Reprocesses Umbilical Cable
Applicant
Innovative Health, LLC
Decision
Substantially Equivalent
Date received
2022-06-27
Decision date
2022-08-06
Days to decision
40 days
Clearance type
Traditional
Product code
NLH
Device class
2
Regulation number
870.1220
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Scottsdale, AZ, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter (K252405)Surgical Instrument Service and Savings, Inc.2025-11-26
Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter (K250772)Surgical Instrument Service and Savings, Inc.2025-07-11
Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter (K242225)Surgical Instrument Service and Savings, Inc.2024-11-29
Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT) (K241224)Surgical Instrument Service and Savings Inc.(Dba Medline Ren2024-11-15
Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter (K240826)Sterilmed, Inc.2024-10-11
Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401 (K241156)Surgical Instrument Service and Savings, Inc.2024-09-14
Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter (K233825)Innovative Health2024-06-07
Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) (K240972)Surgical Instrument Service and Savings, Inc.2024-06-07
Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter (K221067)Surgical Instrument Service and Savings, Inc.2023-05-31
Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters (K211276)Innovative Health, LLC2021-09-15
Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) (K203655)Innovative Health, LLC2021-05-04
Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled (K200205)Stryker Sustainability Solutions2020-05-13

Recalls involving this device

No recalls on record reference this clearance.