510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Invatec Innovative Technologies, S.r.l.

Plymouth, MN, US

Invatec Innovative Technologies, S.R.L. appears in FDA device records in Plymouth, MN. FDA records list 10 510(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
10
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 10 510(k) clearances for Invatec Innovative Technologies, S.r.l. between 2004 and 2009. The busiest year on record is 2005, with 6. The most recent is 2009, with 1.

Clearances by year, as a table
510(k) clearance decisions for Invatec Innovative Technologies, S.r.l., by decision year
YearClearances
20042
20056
20061
20091
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K083919AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETERDQYSubstantially Equivalent
K062809ADMIRAL XTREME PTA CATHETERDQYSubstantially Equivalent
K052791MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETERDQYSubstantially Equivalent
K051917DIVER C.E. CATHETERQEZSubstantially Equivalent
K050756SKIPPER AND SKIPPER RACE GUIDEWIREDQXSubstantially Equivalent
K050276DIVER C.E. CATHETERQEZSubstantially Equivalent
K050073MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETERDQYSubstantially Equivalent
K042624AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETERDQYSubstantially Equivalent
K042538SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SAEXXXXXXXXXDQYSubstantially Equivalent
K042537SUBMARINE PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SUVXXXXXXXXXDQYSubstantially 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

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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