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FDA 510(k)

PERITONEAL DIAL. TITA. CATH ADAPTER & LOCKING CAP

K-Number: K894783 · 1989-09-07

ApplicantBaxter Healthcare Corp
Decision Date1989-09-07
Product CodeKDJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PERITONEAL DIAL. TITA. CATH ADAPTER & LOCKING CAP is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1989-09-07 under 510(k) number K894783. 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 PERITONEAL DIAL. TITA. CATH ADAPTER & LOCKING CAP?

PERITONEAL DIAL. TITA. CATH ADAPTER & LOCKING CAP is a medical device that received FDA 510(k) clearance on 1989-09-07. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K894783.

When did PERITONEAL DIAL. TITA. CATH ADAPTER & LOCKING CAP receive FDA 510(k) clearance?

PERITONEAL DIAL. TITA. CATH ADAPTER & LOCKING CAP received FDA 510(k) clearance on 1989-09-07, under 510(k) number K894783.

Who is the listed applicant for PERITONEAL DIAL. TITA. CATH ADAPTER & LOCKING CAP?

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

What is the FDA product code for PERITONEAL DIAL. TITA. CATH ADAPTER & LOCKING CAP?

The FDA product code for PERITONEAL DIAL. TITA. CATH ADAPTER & LOCKING CAP is KDJ.

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Other records listing Baxter Healthcare Corp as applicant

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K190910PrisMax System Version 2K163530PrisMax Control UnitK132734NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETSK130245LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFOK123874INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL SK123868INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET

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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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