Luther Medical Products, Inc.

Walker, MI, US

Luther Medical Products, Inc. appears in FDA device records in Walker, MI. FDA records list 17 510(k) clearances between 1980-08-20 and 1998-11-30, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 17
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 17 510(k) clearances for Luther Medical Products, Inc. between 1980 and 1998. The busiest year on record is 1993, with 4. The most recent is 1998, with 3.

Clearances by year, as a table

510(k) clearance decisions for Luther Medical Products, Inc., by decision year
Year	Clearances
1980	1
1982	2
1986	1
1987	1
1989	1
1993	4
1994	4
1998	3

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K982797	BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB	DYB	Substantially Equivalent	1998-11-30
K980090	ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM)	LJS	Substantially Equivalent	1998-03-24
K974543	L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER	FOZ	Substantially Equivalent	1998-02-10
K940198	L-CATH CONNECTOR ASSEMBLY	GCD	Substantially Equivalent	1994-12-15
K942103	L-CATH CATHETER SYSTEM - PORT L-CATH	LJT	Substantially Equivalent	1994-07-26
K930473	ONECATH L-CATH CATHETER SYSTEM	LJS	Unknown	1994-04-07
K925236	L CATH(R) CATHETER SYSTEM	LJS	Substantially Equivalent	1994-03-22
K920755	L-CATH PEEL AWAY SYSTEM CATHETER	LJS	Substantially Equivalent	1993-06-07
K925979	DUAL LUMEN L-CATH CATHETER SYSTEM	DQX	Substantially Equivalent	1993-05-27
K924968	L-CATH PEEL-AWAY CATHETER SYSTEM	FOZ	Substantially Equivalent	1993-05-21
K924562	CATHETER INTRODUCER	DYB	Substantially Equivalent	1993-02-25
K884806	LUMED EXPANDO-CATH, ACTIV	FOZ	Substantially Equivalent	1989-02-08
K871546	SAFESIDE(TM) LUMED	FOZ	Substantially Equivalent	1987-06-17
K853348	L-CATH EXPANDO CATH	FOZ	Substantially Equivalent	1986-01-09
K822217	THERMOTHERAPY	LKX	Substantially Equivalent	1982-09-24
K820102	SUBCLAVIAN JUGULAR CATHETER SET	DQR	Substantially Equivalent	1982-01-29
K801575	L-CATH INTRAVENOUS PLACEMENT UNIT	FOZ	Substantially Equivalent	1980-08-20

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain