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

Mountain View, CA, US

Acumen Medical, Inc. appears in FDA device records in Mountain View, CA. FDA records list 12 510(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
12
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 12 510(k) clearances for Acumen Medical, Inc. between 2004 and 2009. The busiest year on record is 2006, with 3. The most recent is 2009, with 1.

Clearances by year, as a table
510(k) clearance decisions for Acumen Medical, Inc., by decision year
YearClearances
20042
20052
20063
20073
20081
20091
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K083855MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59DYBSubstantially Equivalent
K080500MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7DYBSubstantially Equivalent
K070396MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45DYBSubstantially Equivalent
K070051ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEMDQYSubstantially Equivalent
K070197ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STYDYBSubstantially Equivalent
K062145MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90DYBSubstantially Equivalent
K0620847F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67DQYSubstantially Equivalent
K053400ACUMEN SINGLE-LUMEN DELIVERY SHEATHDYBSubstantially Equivalent
K051515MODIFIED ACUMEN SHEATH, MODEL TTW 10-65DYBSubstantially Equivalent
K050015MODIFIED ACUMEN SHEATH, MODEL TTWO767DYBSubstantially Equivalent
K042381CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508DQYSubstantially Equivalent
K042376ACUMEN SHEATH, MODEL TTW7807DYBSubstantially 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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Data as of , FDA export datePage updated Source: openFDA, public domain