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FDA 510(k)

DELTEC INSULIN INFUSION PUMP AND ACCESSORIES

K-Number: K020655 · 2002-08-13

ApplicantDeltec, Inc.
Decision Date2002-08-13
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DELTEC INSULIN INFUSION PUMP AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Deltec, Inc.. It received FDA 510(k) clearance on 2002-08-13 under 510(k) number K020655. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DELTEC INSULIN INFUSION PUMP AND ACCESSORIES?

DELTEC INSULIN INFUSION PUMP AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2002-08-13. The listed applicant is Deltec, Inc.. The 510(k) number is K020655.

When did DELTEC INSULIN INFUSION PUMP AND ACCESSORIES receive FDA 510(k) clearance?

DELTEC INSULIN INFUSION PUMP AND ACCESSORIES received FDA 510(k) clearance on 2002-08-13, under 510(k) number K020655.

Who is the listed applicant for DELTEC INSULIN INFUSION PUMP AND ACCESSORIES?

The FDA 510(k) record lists Deltec, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DELTEC INSULIN INFUSION PUMP AND ACCESSORIES?

The FDA product code for DELTEC INSULIN INFUSION PUMP AND ACCESSORIES is LZG.

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Other records listing Deltec, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K031361CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOPK030983TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POYK022221TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERSK021999GRIPPER PLUS NEEDLE

Related Devices (Code: LZG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262153Pivot Insulin Delivery SystemModular Medical, Inc.K253534Pivot Insulin Delivery SystemModular MedicalK240158Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc.K241622Extended Reservoir; MiniMed ReservoirMedtronic MinimedK223372Omnipod GO Insulin Delivery DeviceInsulet CorporationK210714Extended ReservoirMedtronic Minimed, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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