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FDA 510(k)

CADD-PRIZM MODEL 6100 PUMP

K-Number: K960826 · 1996-08-23

ApplicantSims Deltec, Inc.
Decision Date1996-08-23
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CADD-PRIZM MODEL 6100 PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Sims Deltec, Inc.. It received FDA 510(k) clearance on 1996-08-23 under 510(k) number K960826. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CADD-PRIZM MODEL 6100 PUMP?

CADD-PRIZM MODEL 6100 PUMP is a medical device that received FDA 510(k) clearance on 1996-08-23. The listed applicant is Sims Deltec, Inc.. The 510(k) number is K960826.

When did CADD-PRIZM MODEL 6100 PUMP receive FDA 510(k) clearance?

CADD-PRIZM MODEL 6100 PUMP received FDA 510(k) clearance on 1996-08-23, under 510(k) number K960826.

Who is the listed applicant for CADD-PRIZM MODEL 6100 PUMP?

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

What is the FDA product code for CADD-PRIZM MODEL 6100 PUMP?

The FDA product code for CADD-PRIZM MODEL 6100 PUMP is FRN.

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Other records listing Sims 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.

K010426PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETERK000842CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEMK000942CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090K994216PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEMK992697PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEMK992880P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM

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Related Devices (Code: FRN)

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.

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Official Source

View on FDA Database →

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

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