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FDA 510(k)

ABBOTT SMART CAP

K-Number: K921818 · 1994-03-28

ApplicantAbbott Laboratories
Decision Date1994-03-28
Product CodeKDJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ABBOTT SMART CAP is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1994-03-28 under 510(k) number K921818. The device is classified under product code KDJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT SMART CAP?

ABBOTT SMART CAP is a medical device that received FDA 510(k) clearance on 1994-03-28. The listed applicant is Abbott Laboratories. The 510(k) number is K921818.

When did ABBOTT SMART CAP receive FDA 510(k) clearance?

ABBOTT SMART CAP received FDA 510(k) clearance on 1994-03-28, under 510(k) number K921818.

Who is the listed applicant for ABBOTT SMART CAP?

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

What is the FDA product code for ABBOTT SMART CAP?

The FDA product code for ABBOTT SMART CAP is KDJ.

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Other records listing Abbott Laboratories as applicant

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Related Devices (Code: KDJ)

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.

K250404stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inchFresenius Medical Care Renal Therapies Group, LLCK231849MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483Baxter HealthcareK21401615L Cycler Drainage BagBaxter Healthcare CorporationK192705MiniCap Extended Life PD Transfer SetsBaxter HealthcareK173593stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inchFresenius Medical Care Renal Therapies Group, LLCK173651Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain SetFresenius Medical Care Renal Therapies Group, LLC

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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