510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Route 92 Medical, Head Quarters

San Mateo, CA, US

Route 92 Medical, Head Quarters appears in FDA device records in San Mateo, CA. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls 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
5
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Route 92 Medical, Head Quarters 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.

  • Route 92 Medical, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 14 510(k) clearances for Route 92 Medical, Head Quarters between 2018 and 2025. The busiest year on record is 2020, with 4. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Route 92 Medical, Head Quarters, by decision year
YearClearances
20182
20191
20204
20211
20221
20232
20242
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K243601Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing SetNRYSubstantially Equivalent
K2405298F Modified Sheath SystemQJPSubstantially Equivalent
K233329Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing SetNRYSubstantially Equivalent
K231583Route 92 Medical Full Length 054 Access SystemQJPSubstantially Equivalent
K223530Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing SetNRYSubstantially Equivalent
K222743Route 92 Medical Full Length 070 Access SystemQJPSubstantially Equivalent
K210635Route 92 Medical Full Length 088 Access SystemQJPSubstantially Equivalent
K203043Route 92 Medical 070 Access SystemQJPSubstantially Equivalent
K201518Route 92 Medical 088 Access SystemQJPSubstantially Equivalent
K200121Route 92 Medical 088 Access System, 110 cmQJPSubstantially Equivalent
K191717Route 92 Medical Sheath SystemDQYSubstantially Equivalent
K190431Route 92 Medical Delivery CatheterDQYSubstantially Equivalent
K182512Route 92 Medical Delivery CatheterDQYSubstantially Equivalent
K180201Route 92 Medical Access SystemDQYSubstantially Equivalent

Registered establishments

FDA registered establishments for Route 92 Medical, Head Quarters, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30165229673016522967Route 92 Medical, Head Quarters155 Bovet Road, San Mateo, CA 94402 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-1614-2024Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovasculature and aspiration of thrombus in ischemic stroke patients.Their is the potential for distal tip separation at the proximal marker band of the delivery cathetersClass IOpen, Classified
Z-1613-2024Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.Their is the potential for distal tip separation at the proximal marker band of the delivery cathetersClass IOpen, Classified
Z-1612-2024Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.Their is the potential for distal tip separation at the proximal marker band of the delivery cathetersClass IOpen, Classified
Z-1611-2024Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.Their is the potential for distal tip separation at the proximal marker band of the delivery cathetersClass IOpen, Classified
Z-1610-2024Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.Their is the potential for distal tip separation at the proximal marker band of the delivery catheters.Class IOpen, Classified

Verification record

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