ACME-MONACO CORP.

FDA Device Registration & Listing · NEW BRITAIN, CT, US · Registration 1293141

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1293141
FEI Number
1293141
Entity Name
ACME-MONACO CORP.
City/State/Country
NEW BRITAIN, CT, US
Establishment Address
75 Winchell Rd, NEW BRITAIN, CT 06052, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
ACME-MONACO CORP. (Owner Number: 1293141)
Owner / Operator Contact Address
75 WINCHELL DR., --, New Britain, CT 06052, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

MULTIPLE PRODUCTS MULTIPLE PRODUCTS Guidewire MULTIPLE PRODUCTS MULTIPLE PRODUCTS Multiple MULTIPLE PRODUCTS Acme Monaco Slidewire Multiple

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 1992-08-06
ECN Clamp, Wire, Orthodontic Dental Class 1 872.5410 1992-08-06
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2013-06-06
ECO Spring, Orthodontic Dental Class 1 872.5410 1992-08-06
DZC Wire, Orthodontic Dental Class 1 872.5410 1992-08-06
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-11-27
EJF Bracket, Metal, Orthodontic Dental Class 1 872.5410 1992-08-06
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2012-10-26
DRB Stylet, Catheter Cardiovascular Class 2 870.1380 2007-11-27

Official Correspondent

REBECCA KARABIN

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ACME-MONACO CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007064586 Acme Monaco Asia Pte. Ltd. Singapore Central Singapore, SG
1222301 ACME-MONACO CORP. PRESQUE ISLE, ME, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K900590 Biosearch Medical Products, Inc. BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING 1990-08-02
K102548 Footprint Medical, Inc. FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE 2010-11-26
K955248 United States Endoscopy Group, Inc. U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT 1996-05-21
K872921 Medical Support, Inc. MSS ENTERAL DELIVERY SET 1987-12-03
K180622 Covidien Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port 2018-10-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0030-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1293141. Last updated year: 2026. Please use registration number 1293141 when referencing this establishment in official correspondence.
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