TIERCEL SURGICAL

FDA Device Registration & Listing · New Britain, PA, US · Registration 3027595864

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3027595864
FEI Number
3027595864
Entity Name
TIERCEL SURGICAL
City/State/Country
New Britain, PA, US
Establishment Address
75 Britain Drive, New Britain, PA 18901, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Tiercel Surgical (Owner Number: 10088298)
Owner / Operator Contact Address
75 Britain Drive, New Britain, PA 18901, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Bashir™ 35 Endovascular Catheter, Bashir™ S-B 35 Endovascular Catheter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2023-06-26
QEY Mechanical Thrombolysis Catheter Cardiovascular Class 2 870.5150 2023-06-26
QEY Mechanical Thrombolysis Catheter Cardiovascular Class 2 870.5150 2023-06-26
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2023-06-26
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2023-06-26
QEY Mechanical Thrombolysis Catheter Cardiovascular Class 2 870.5150 2023-06-26
QEY Mechanical Thrombolysis Catheter Cardiovascular Class 2 870.5150 2024-12-05
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2024-12-05
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2023-06-26
QEY Mechanical Thrombolysis Catheter Cardiovascular Class 2 870.5150 2023-06-26

Official Correspondent

Molly Murray

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Tiercel Surgical
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K792141 Pharmaseal Div., Baxter Healthcare Corp. CONTINUOUS FLUSH DEVICE 1979-12-05
K924661 Baxter Healthcare Corp SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER 1993-04-08

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027595864. Last updated year: 2026. Please use registration number 3027595864 when referencing this establishment in official correspondence.
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