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Vascular Technology Incorporated

Nashua, NH, US

VASCULAR TECHNOLOGY INCORPORATED appears in FDA device records in Nashua, NH. FDA records list 11 510(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
11
PMA records
0
Recall records
5
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Vascular Technology Incorporated 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.

  • Vascular Technology, Inc.enforcement report, recall

510(k) clearance history

FDA records hold 11 510(k) clearances for Vascular Technology Incorporated between 1985 and 2008. The busiest year on record is 1986, with 2. The most recent is 2008, with 1.

Clearances by year, as a table
510(k) clearance decisions for Vascular Technology Incorporated, by decision year
YearClearances
19851
19862
19871
19892
19931
19941
20001
20031
20081
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K082870VTI INTRAOPERATIVE DOPPLER SYSTEMSDPWSubstantially Equivalent
K031091VTI 20 MHZ GATED DOPPLERDPWSubstantially Equivalent
K002990VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001HBLSubstantially Equivalent
K944764VTI DISPOSABLE PRESSURE DISPLAY SETDXSSubstantially Equivalent
K922738VTI OXYGEN ANALYZERCCLSubstantially Equivalent
K890058VASCULAR TECHNOLOGY UNIOX OXYGEN ALARMCCLSubstantially Equivalent
K883960GIPHY MONITORFFTSubstantially Equivalent
K864583CARDIAC PERFORMANCE MONITORDQKSubstantially Equivalent
K862114KHURI REGIONAL TISSUE PH MONITORCBZSubstantially Equivalent
K862113NO. 100352 GALVANIC OXYGEN SENSORCCLSubstantially Equivalent
K852275VASCULAR TECH # 100123 POLAROGRAPHIC OXGYEN SENSORCCLSubstantially Equivalent

Registered establishments

FDA registered establishments for Vascular Technology Incorporated, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
12210721221072VASCULAR TECHNOLOGY INCORPORATED12 MURPHY DR., NASHUA, NH 03062 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-3026-2018VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular.Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiverClass IITerminated
Z-2001-2014VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4, REF 108660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.Report of the product penetrating the sterile barrier; this could render the product unsterile.Class IITerminated
Z-2000-201407-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.Report of the product penetrating the sterile barrier; this could render the product unsterile.Class IITerminated
Z-1999-201407-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.Report of the product penetrating the sterile barrier; this could render the product unsterile.Class IITerminated
Z-1998-201407-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.Report of the product penetrating the sterile barrier; this could render the product unsterile.Class IITerminated

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