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

Kirkland, WA, US

Pathway Medical Technologies, Inc. appears in FDA device records in Kirkland, WA. FDA records list 16 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
16
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 16 510(k) clearances for Pathway Medical Technologies, Inc. between 2008 and 2012. The busiest year on record is 2009, with 6. The most recent is 2012, with 1.

Clearances by year, as a table
510(k) clearance decisions for Pathway Medical Technologies, Inc., by decision year
YearClearances
20083
20096
20104
20112
20121
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K120242JETSTREAM NAVITUS L SYSTEMMCWSubstantially Equivalent
K111229JETSTREAM G3 (R) SF 1.6 SYSTEMMCWSubstantially Equivalent
K110626JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEMMCWSubstantially Equivalent
K101334JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CONMCWSubstantially Equivalent
K101221JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100MCWSubstantially Equivalent
K100462JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100MCWSubstantially Equivalent
K093918JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE)MCWSubstantially Equivalent
K093456JETSTREAM G3 SYSTEMMCWSubstantially Equivalent
K092332JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE)MCWSubstantially Equivalent
K091509JETSTREAM G2 NXT SYSTEM, MODEL PV20300MCWSubstantially Equivalent
K090325JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE)MCWSubstantially Equivalent
K083489JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300MCWSubstantially Equivalent
K083837JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE)MCWSubstantially Equivalent
K082664JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100MCWSubstantially Equivalent
K082186MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEMMCWSubstantially Equivalent
K081328PATHWAY PV ATHERECTOMY SYSTEMMCWSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

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

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

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