510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Thrombolex, Inc.

New Britain, PA, US

THROMBOLEX, INC. appears in FDA device records in New Britain, PA. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
6
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 6 510(k) clearances for Thrombolex, Inc. between 2019 and 2023. The busiest year on record is 2019, with 3. The most recent is 2023, with 2.

Clearances by year, as a table
510(k) clearance decisions for Thrombolex, Inc., by decision year
YearClearances
20193
20211
20232
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K231653BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular CatheterQEYSubstantially Equivalent
K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101QEYSubstantially Equivalent
K211061BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240)QEYSubstantially Equivalent
K193071Bashir Plus Endovascular CatheterQEYSubstantially Equivalent
K192598Bashir S-B Endovascular Catheter, Ref. No. 7101QEYSubstantially Equivalent
K183290Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200QEYSubstantially Equivalent

Registered establishments

FDA registered establishments for Thrombolex, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30154891453015489145THROMBOLEX, INC.75 Britain Dr., New Britain, PA 18901 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain