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

Chaska, MN, US

Lake Region Medical appears in FDA device records in Chaska, MN. FDA records list 17 510(k) clearances between and , no PMA records and 3 registered establishments. 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
17
PMA records
0
Recall records
0
Registered establishments
3

510(k) clearance history

FDA records hold 17 510(k) clearances for Lake Region Medical between 2008 and 2026. The busiest year on record is 2014, with 6. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Lake Region Medical, by decision year
YearClearances
20081
20112
20132
20146
20151
20161
20211
20221
20241
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253746Enroute 0.014'' Transcarotid GuidewireDQXSubstantially Equivalent
K242824PTFE GuidewireDQXSubstantially Equivalent
K221575Pre-Formed BlueDQXSubstantially Equivalent
K211741Pre-Formed Extra Support GuidewireDQXSubstantially Equivalent
K160643ENROUTE 0.014 GuidewireDQXSubstantially Equivalent
K151244Pre-Formed GuidewireDQXSubstantially Equivalent
K140536HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIREDQXSubstantially Equivalent
K142393PREDICATE III GUIDEWIREDQXSubstantially Equivalent
K142397Predicate III GuidewireOCYSubstantially Equivalent
K140482MANDREL GUIDEWIREOCYSubstantially Equivalent
K133155HYDROPHILIC COATED GUIDEWIREDQXSubstantially Equivalent
K140485MANDREL GUIDEWIREDQXSubstantially Equivalent
K130798PRE-FORMED GUIDEWIRESDQXSubstantially Equivalent
K124052OSTAVI HYDROPHILIC GUIDEWIREOCYSubstantially Equivalent
K112381HI TORQUE CONNECT GUIDEWIREDQXSubstantially Equivalent
K111288ANCHORWIRE GUIDEWIREDQXSubstantially Equivalent
K080508MANDREL GUIDEWIRES OR M-WIREOCYSubstantially Equivalent

Registered establishments

FDA registered establishments for Lake Region Medical, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96814773002807439LAKE REGION MEDICAL LIMITEDBUTLERSLAND, NEW ROSS Wexford -- IE2026and 12 more, listed in full below
21266662126666Lake Region Medical340 Lake Hazeltine Dr, CHASKA, MN 55318 US2026and 18 more, listed in full below
30040634943004063494Lake Region Medical13024 NORTH MAIN ST., TRENTON, GA 30752 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