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

Campbell, CA, US

Verge Medical Inc. appears in FDA device records in Campbell, CA. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
14
PMA records
0
Recall records
1
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Verge Medical Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Ostial Corporation510(k), enforcement report, recall

510(k) clearance history

FDA records hold 14 510(k) clearances for Verge Medical Inc. between 2011 and 2026. The busiest year on record is 2012, with 6. The most recent is 2026, with 2.

Clearances by year, as a table
510(k) clearance decisions for Verge Medical Inc., by decision year
YearClearances
20112
20126
20131
20141
20151
20161
20262
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K254022FLASH Flex™ Aorto-Ostial Angioplasty SystemLOXSubstantially Equivalent
K253730RoVo Mechanical Thrombectomy SystemQEWSubstantially Equivalent
K152485FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cmLOXSubstantially Equivalent
K150946FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cmLITSubstantially Equivalent
K133861FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CMLITSubstantially Equivalent
K131450FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0LOXSubstantially Equivalent
K122178FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1LOXSubstantially Equivalent
K122379FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CMLITSubstantially Equivalent
K121175FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CMLITSubstantially Equivalent
K113775FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MMLOXSubstantially Equivalent
K113582ARCHSTENT BILIARY SYSTEMFGEUnknown
K120738FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CMLITSubstantially Equivalent
K111284FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CMLOXSubstantially Equivalent
K102482FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM; FLASH PTA BALLOON DILATATION CATHETER 6MM X 19MM X 135CMLITSubstantially Equivalent

Registered establishments

FDA registered establishments for Verge Medical Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30087008173008700817Verge Medical Inc.747 Camden Ave Ste A, Campbell, CA 95008 US2026

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

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2309-2021FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BAAngioplasty system has a manufacturing issue that has the potential to result in difficulty deflating the outer balloon, which may result in increased risk of access site complications.Class IITerminated

Verification record

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