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

Boca Raton, FL, US

VYCOR MEDICAL INC appears in FDA device records in Boca Raton, FL. FDA records list 2 510(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
2
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for Vycor Medical, Inc. between 2006 and 2021. The busiest year on record is 2006, with 1. The most recent is 2021, with 1.

Clearances by year, as a table
510(k) clearance decisions for Vycor Medical, Inc., by decision year
YearClearances
20061
20211
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K202694Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)GZTSubstantially Equivalent
K060973VYCOR SURGICAL ACCESS SYSTEMSGZTSubstantially Equivalent

Registered establishments

FDA registered establishments for Vycor Medical, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30058808443005880844VYCOR MEDICAL INC951 BROKEN SOUND PKWY STE 320, Boca Raton, FL 33487 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-0673-2013Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel port that are secured by a spring-loaded latch. Each device allows for the gentle retraction of tissue, visualization of the surgical site and for the smooth manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes.Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device.Class ITerminated

Verification record

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