Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1226230

FEI Number

3002836339

Entity Name

Vericel Corporation

City/State/Country

CAMBRIDGE, MA, US

Establishment Address

64 Sidney St, CAMBRIDGE, MA 02139, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Vericel (Owner Number: 10051107)

Owner / Operator Contact Address

64 Sidney Street, Cambridge, MA 02139, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Arthroscopic Measurement Probe BD Vacutainer EDTA (K2) Blood Collection Tubes 15mm x 4cm Cannula Assembly 15mm x 3cm Cannula Assembly 14mm x 26mm Max Arthroscopic Cutter 18mm x 4cm Cannula Assembly 3.6mm Rake Curette 4mm x 5mm Square Curette 14mm x 26mm Min Arthroscopic Cutter 17mm x 28mm Max Arthroscopic Cutter 12mm x 21mm Min Arthroscopic Cutter 6.5mm Open-Ring Curette Skin Biopsy Transport Medium Cartilage Biopsy Transport Medium Vericel Surgical Implantation Surgical Implantation MACI Implantation Cartilage Biopsy Transport Kit Skin Biopsy Transport Kit cultured epithelial autograft Vonco 95kPa VonSeal MACI Implantation Kit Vericel Surgical Implantation Kit MACI Surgical Implantation Kit 18mm V-Shuttle Delivery Device 15mm V-Shuttle Delivery Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2024-06-03
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2022-09-02
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2024-05-28
KIT	Media And Components, Synthetic Cell And Tissue Culture	Hematology	Class 1	864.2220	2022-12-09
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2022-03-22
KDW	Container, Specimen Mailer And Storage, Temperature Controlled, Sterile	Pathology	Class 1	864.3250	2016-02-04
OCE	Cultured Epithelial Autograft	Unknown	Class f	N/A	2016-02-04
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2022-11-09
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2022-06-14
HWQ	Passer	Orthopedic	Class 1	888.4540	2024-05-28

Official Correspondent

Gina Prochilo-Cawston

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Vericel

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22
K832690	Sigma Chemical Co.	MINIMUM ESSENTIAL MED. EAGLE M0268	1983-09-12
K861867	Hazleton Research Products, Inc.	MEM ALPHA EAGLE MEDIUM	1986-05-29
K821916	Dutchland Laboratories, Inc.	IMPROVED MEM-RICHTER'S POWDER MODIF.	1982-07-27
K810767	Dutchland Laboratories, Inc.	RPMI 1640 MEDIUM	1981-05-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Z-0040-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0041-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0042-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0043-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 6mm Offset (Green) Catalog Number: 72201716 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

Similar Registrations

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3011693567	LAMINATE MEDICAL TECHNOLOGIES	Tel Aviv, IL
3009134882	DMED	Seongnam-si Gyeonggi, KR
1057425	SOUTHEASTERN TECHNOLOGY dba Autocam Medical	Murfreesboro, TN, US
8044098	HGR INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1226230. Last updated year: 2026. Please use registration number 1226230 when referencing this establishment in official correspondence.